Sr. Manager/ Associate Director, Biostatistics

🏢 Summary: The Senior Manager / Associate Director, Statistical Programming leads and oversees statistical programming activities across clinical development programs, ensuring high-quality, regulatory-compliant deliverables for trials and submissions. The role drives strategy, vendor oversight, CDISC standards implementation, and cross-functional collaboration while mentoring programming teams. It offers significant impact on regulatory submissions, data standards, and biometrics process innovation. 🗂️ Requirements: Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or related quantitative field (or Bachelor’s with significant relevant experience), 7+ years (Senior Manager) or 9+ years (Associate Director) statistical programming experience in biotech, pharma, or CRO, Experience as lead programmer supporting clinical development programs and regulatory submissions, Advanced proficiency in SAS programming (Base, Stat, Graph, Macro, SQL), Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), Strong knowledge of ICH, GCP, FDA, EMA regulatory requirements, Experience managing CROs, FSPs, or external programming vendors 📃 Skills: SAS, BaseSAS, SASStat, SASGraph, SASMacro, SQL, R, CDISC, SDTM, ADaM, Define.xml, Pinnacle21, ICH, GCP, FDA, EMA 🏢 Description: Position Summary: The Senior Manager / Associate Director, Statistical Programming will provide strategic and operational leadership for statistical programming activities across one or more clinical development programs. This individual will be responsible for the planning, execution, oversight, and delivery of statistical programming outputs supporting clinical trials, regulatory submissions, publications, and internal decision-making. The successful candidate will serve as a key partner to Biostatistics, Clinical Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure high-quality, compliant, and timely programming deliverables. This role offers the opportunity to influence programming standards, mentor team members, and contribute to the continued growth of the Biometrics organization. Essential Duties and Responsibilities: Statistical Programming Leadership Lead statistical programming activities for one or more clinical studies, programs, or therapeutic areas. Provide strategic oversight and accountability for the development, validation, and delivery of statistical programming outputs, including SDTM and ADaM data packages (SDRG, ADRG, Define.xml, submission-ready datasets), and Tables, Listings, Figures (TLFs). Ensure programming deliverables meet quality, timeline, regulatory, and audit-readiness requirements. Support regulatory submissions, health authority interactions, publications, and ad hoc analyses. Vendor and CRO Oversight Manage and oversee outsourced statistical programming activities conducted by CROs and external partners. Review and validate datasets, TLFs, specifications, and programming documentation generated by vendors. Monitor vendor performance, timelines, quality metrics, and resource allocation to ensure successful project execution. Establish and maintain effective partnerships with external programming and biometrics vendors. Cross-Functional Collaboration Partner closely with Biostatistics, Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other stakeholders to deliver high-quality clinical data and analyses. Review and provide programming input on Protocols, Statistical Analysis Plans (SAPs), Data Management Plans (DMPs), CRFs, annotated CRFs, data review plans, and dataset and TLF specifications. Collaborate on the development of data review tools, dashboards, visualizations, and other statistical applications to support clinical development activities. Communicate programming strategies, timelines, risks, and resource needs to project teams and leadership. Standards, Innovation, and Process Improvement Contribute to the development, implementation, and continuous improvement of internal statistical programming standards, processes, and best practices. Assist with establishing framework of programming environment, including library of macros. Drive adoption of CDISC standards, programming automation, and innovative analytical solutions. Maintain expertise in regulatory requirements, industry standards, and emerging technologies related to statistical programming. Support inspection readiness and represent Statistical Programming during audits and regulatory inspections as needed. Team Leadership and Development Mentor, coach, and develop junior statistical programmers to support individual growth and organizational success. Provide leadership and technical guidance to internal and external programming teams. Participate in recruiting, onboarding, and developing programming talent. Foster an inclusive, collaborative, and psychologically safe environment that encourages innovation, learning, and accountability. Required Education and Experience: Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline. Bachelor's degree with significant relevant experience will also be considered. Sr Manager: 7+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry; Associate Director: 9+ years of experience. Demonstrated experience serving as a lead programmer supporting clinical development programs and regulatory submissions. Advanced proficiency in SAS programming, including Base SAS, Stat, Graph, Macro, SQL, and generation of submission-ready deliverables. Working knowledge of R or other modern statistical programming languages is a plus. Experience with producing publication-quality statistical graphics using SAS/R is a plus. Experience with building/contributing to global SAS macro library for TFL generation is highly desirable. Extensive experience with CDISC standards, including SDTM, ADaM, Define.xml, controlled terminology, and regulatory submission requirements. Experience with Pinnacle 21 is a plus. Strong understanding of ICH guidelines, GCP, FDA, EMA, and other global regulatory requirements. Experience managing external CROs, FSPs, or programming vendors. Excellent project management, organizational, communication, and stakeholder management skills. Preferred Experience supporting multiple clinical programs from early development through regulatory submission. Experience implementing programming standards, automation initiatives, or modern analytics platforms.

🏢 Summary: Leadership role overseeing clinical data management across development programs, ensuring high-quality, compliant clinical trial data from study start-up through database lock and regulatory submission. The position drives data strategy, database design, vendor oversight, PK data review, and cross-functional collaboration to support successful clinical and regulatory outcomes. Strong focus on regulatory compliance, inspection readiness, and industry data standards. 🗂️ Requirements: BS/BA in bioscience, engineering, computer science, medical or related field, 6+ years (MS) or 9+ years (BS) clinical data management experience for Senior Manager, 9+ years (MS) or 12+ years (BS) clinical data management experience for Associate Director, Experience leading data management from study start-up through database lock, Strong vendor and CRO oversight experience, Experience supporting regulatory submissions and inspection readiness, Knowledge of ICH-GCP and FDA regulations, Experience with EDC systems (e.g., Medidata Rave) 📃 Skills: EDC, Medidata, Rave, CDISC, CDASH, SDTM, MedDRA, WHODrug, ICH-GCP, FDA, 21CFRPart11, PK, UAT, SOP, GCDMP 🏢 Description: Position Summary: Senior Manager / Associate Director, Clinical Data Management to provide leadership and oversight of clinical data management activities across one or more development programs. This individual is responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness. Working closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Clinical Pharmacology, Pharmacovigilance, Regulatory Affairs, Information Technology, and external partners, this role serves as the Data Management lead for assigned studies and programs, driving data strategy, vendor oversight, process excellence, and inspection readiness. Essential Duties and Responsibilities: Clinical Data Management Leadership - Lead clinical data management activities for assigned studies (especially PK trials) from protocol development through database lock and submission readiness. - Serve as primary point of contact for CROs and vendors, ensuring data delivery on time, within budget, and in compliance with ICH-GCP guidelines. - Represent Data Management on cross-functional study teams, aligning deliverables with study objectives, timelines, and regulatory requirements. - Develop and execute study-specific data management strategies to ensure high-quality, analyzable clinical trial data. - Oversee and maintain Data Management Plans (DMPs), data review plans, and study-level documentation. Database Design, Build, and Validation - Collaborate on design and review of electronic Case Report Forms (eCRFs). - Develop and review database build specifications, edit check specifications, CRF completion guidelines, and validation plans. - Lead User Acceptance Testing (UAT) and oversee database go-live readiness. - Ensure databases are designed and validated in accordance with protocol requirements, CDASH standards, and best practices. Data Review and Quality Oversight - Lead ongoing PK and clinical data review, discrepancy management, query generation, and resolution. - Establish and monitor data quality metrics to ensure accuracy, consistency, completeness, and analysis readiness. - Oversee reconciliation activities including SAEs, laboratory data, medical coding, protocol deviations, and external data sources. - Manage MedDRA and WHODrug coding activities. - Support database lock activities and final data transfers for statistical analysis and regulatory submissions. Vendor and CRO Management - Manage bioanalytical vendors for PK assays and ensure appropriate data collection. - Provide oversight of CROs, EDC providers, specialty laboratories, and other external vendors. - Participate in vendor selection, RFP reviews, and vendor assessments. - Review vendor contracts, data transfer agreements, and service deliverables. - Monitor vendor performance, timelines, quality metrics, and issue resolution. Cross-Functional Collaboration - Partner with Biostatistics and Statistical Programming to support data review, SAP development, listings review, and submission readiness. - Collaborate with Clinical Operations, Clinical Pharmacology, Safety, Regulatory Affairs, and Medical teams to ensure accurate data collection and reporting. - Provide data management updates, risk assessments, and recommendations in study team meetings. - Support preparation and review of clinical study reports, tables, listings, and regulatory submission deliverables. Process Improvement and Compliance - Contribute to development and continuous improvement of Data Management processes, SOPs, standards, and best practices. - Ensure compliance with ICH-GCP, FDA regulations, CDISC/CDASH standards, GCDMP guidelines, and company procedures. - Support inspection readiness and participate in regulatory inspections and audits. - Mentor junior team members and contribute to team development. Required Education and Experience: - BS/BA in bioscience, engineering, computer science, medical training, or related field; MS/MA preferred. - Senior Manager: 6+ years (MS/MA) or 9+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Associate Director: 9+ years (MS/MA) or 12+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Experience leading data management from study start-up through database lock. - Strong vendor and CRO oversight experience. - Experience supporting regulatory submissions and inspection readiness. Preferred: - Management of PK trial data and clinical pharmacology experience. Additional Skills, Knowledge, and Abilities: - Deep understanding of clinical data management principles and industry standards. - Working knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, CDISC/CDASH, SDTM, MedDRA, and WHODrug. - Experience with EDC systems such as Medidata Rave or equivalent. - Experience with drug development and PK sample collection. - Strong understanding of external data integrations, reconciliation processes, and database lock procedures. - Strong project management, organizational, and problem-solving skills. - Ability to manage multiple priorities in a fast-paced environment.

🏢 Summary: The Director Clinical Data Management leads and oversees all clinical data management activities across multiple clinical trials, ensuring high-quality, inspection-ready data to support regulatory submissions and business objectives. This role sets data strategy, manages CROs and vendors, and drives risk-based quality and process excellence across Phase I–III programs. The position collaborates cross-functionally to deliver compliant data aligned with global regulatory standards. 🗂️ Requirements: BS/BA in Life Sciences, Engineering, Computer Science, Mathematics, Statistics or related field, 12+ years (MS) or 15+ years (BS) in clinical data management in biotech, pharma, or CRO, 5+ years of people management experience, Experience supporting Phase I–III clinical trials, Experience overseeing CROs and external data management vendors, Strong knowledge of CDISC standards, Strong knowledge of GCP and ICH Guidelines, Strong knowledge of FDA and global regulatory requirements, Experience with modern EDC systems (Medidata Rave, Veeva CDMS, Oracle or equivalent), Experience with risk-based quality management (RBQM) 📃 Skills: CDISC, GCP, ICH, FDA, EDC, Medidata, Rave, Veeva, Oracle, RBQM 🏢 Description: Position Summary: The Director Clinical Data Management provides strategic and operational leadership for all clinical data management activities across the clinical development portfolio. This individual serves as the functional leader for Data Management, responsible for establishing data strategy, overseeing external partners, driving process excellence, and ensuring the delivery of high-quality, inspection-ready clinical data that supports clinical development, regulatory submissions, and business objectives. Essential Duties and Responsibilities: Lead and oversee all clinical data management activities across multiple clinical studies and development programs. Develop and implement data management strategies that support clinical, regulatory, and business objectives. Provide leadership and oversight of CROs and technology vendors responsible for data management deliverables. Ensure quality, integrity, consistency, and timely availability of clinical trial data. Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Medical Monitoring, Regulatory Affairs, and Pharmacovigilance teams. Review and approve key study documentation including: Data Management Plans Edit Check Specifications CRF Design Data Review Plans Database Build and Validation Documentation Drive risk-based data review and quality management practices. Support regulatory inspections and audits. Contribute to submission readiness activities including NDA, BLA, MAA, and other global regulatory filings. Build scalable data management processes, standards, and SOPs as the organization grows. Mentor and develop internal team members and consultants. Required Education and Experience: BS/BA degree in Life Sciences, Engineering, Computer Science, Mathematics, Statistics, or related field; MS/MA degree preferred. 12+ (if MS/MA degree) or 15+ (if BS/BA degree) years of clinical data management experience within biotechnology, pharmaceutical, CRO, or related environments. 5+ years of people management experience. Demonstrated experience supporting Phase I–III clinical trials. Experience overseeing external data management vendors and CRO partnerships. Strong understanding of: CDISC standards GCP ICH Guidelines FDA and global regulatory requirements Experience with modern EDC systems such as Medidata Rave, Veeva CDMS, Oracle, or equivalent platforms. Additional Skills, Knowledge, Abilities: Experience with risk-based quality management (RBQM).

🏢 Summary: Senior Scientist role focused on integrating human genetics, multi-omics, and real-world clinical data to support therapeutic target validation, patient stratification, and drug development. The position involves analyzing biobank-scale datasets, EHRs, and population data using computational and statistical methods in a cross-functional research environment. This onsite role in San Diego emphasizes translational genetics, RWE analytics, and scalable data workflows for precision medicine. 🗂️ Requirements: PhD in Biostatistics, Statistical Genetics, Epidemiology, Bioinformatics, Computational Biology, Biomedical Data Science, or related quantitative field, 3+ years of experience in human genetics, biomedical data science, or real-world data analytics, Experience with AI/LLMs for coding, data analysis, literature synthesis, and report generation, Experience working with biobank-scale datasets and real-world data sources, Strong background in statistical genetics, epidemiology, or observational data analysis, Experience integrating genetics, omics, and clinical datasets, Proficiency in R or Python, Ability to work in a fast-paced cross-functional research environment, Valid authorization to work in the country where the role is located 📃 Skills: R, Python, AI, LLMs, RNAi, EHR, OMOP, OHDSI, PheWAS, Biostatistics, Bioinformatics, Epidemiology, Genetics, Omics, MachineLearning, Statistics 🏢 Description: Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company developing RNA interference (RNAi)-based therapies for diseases with a genetic basis. The company leverages RNA chemistries and delivery technologies to silence disease-causing genes and advance therapeutics across multiple disease areas. The Senior Scientist will contribute to the integration of human genetics, multi-omics datasets, and real-world clinical data to generate human evidence supporting therapeutic development. This role works at the intersection of translational genetics, computational biology, and real-world evidence analytics to support target validation, patient stratification, clinical endpoint evaluation, and indication prioritization across therapeutic programs. The successful candidate will collaborate closely with Translational Genetics & Data Science and cross-functional teams including Real-World Evidence, Clinical Development, Translational Medicine, and Discovery Biology. The role leverages large-scale biobank datasets, electronic health records (EHR), and other clinical datasets to translate human data into actionable insights supporting drug discovery and development. This position is onsite 5 days a week in San Diego. Responsibilities - Integrate human genetics, multi-omics datasets, and real-world clinical data to generate evidence supporting therapeutic target validation and indication prioritization - Analyze large-scale biobank and population datasets to identify genetic associations and disease mechanisms relevant to therapeutic programs - Collaborate with the Real-World Evidence (RWE) team to analyze clinical datasets including electronic health records (EHR), claims databases, registries, and longitudinal cohort data - Conduct statistical and computational analyses to characterize disease progression, patient heterogeneity, and treatment outcomes using real-world datasets - Translate genetic findings and clinical observations into hypotheses that inform biomarker strategies, patient stratification, and clinical trial design - Develop scalable analytical workflows to integrate genetics, omics, and clinical data sources - Work collaboratively with cross-functional teams including Discovery Biology, Clinical Development, Translational Medicine, and Data Science to support program decisions - Present results to internal stakeholders and contribute to reports, project discussions, and scientific publications - Manage multiple projects simultaneously and communicate progress and findings effectively to project teams and leadership - Adhere to data governance and compliance standards when working with sensitive clinical datasets Requirements - PhD in Biostatistics, Statistical Genetics, Epidemiology, Bioinformatics, Computational Biology, Biomedical Data Science, or a related quantitative discipline - 3+ years of experience in human genetics, biomedical data science, or real-world data analytics - Strong experience leveraging AI/LLMs to accelerate end-to-end research workflows, including coding, data analysis, literature synthesis, and report generation - Experience working with biobank-scale datasets and real-world data sources such as EHR, claims databases, registries, or population cohorts - Strong background in statistical genetics, epidemiology, or observational data analysis - Experience integrating genetics, omics, and clinical datasets - Proficiency in R or Python for large-scale data analysis - Excellent problem-solving, analytical, and communication skills - Ability to work effectively in a fast-paced, collaborative, and cross-functional research environment Preferred - Post-doc and industry experience - Experience analyzing large-scale population genetics datasets such as UK Biobank, FinnGen, All of Us, or Genomics England - Familiarity with analytical frameworks including phenome-wide association studies (PheWAS), Mendelian randomization, causal inference methods, and survival analysis - Experience working with real-world clinical data models such as OMOP / OHDSI - Experience collaborating with clinical development or real-world evidence teams - Experience applying machine learning or advanced statistical methods to biomedical datasets - Strong interest in translating human data into actionable insights for drug development Benefits - Competitive salary range: $145,000—$165,000 USD - Excellent benefits package - Candidates must have current, valid authorization to work in the country where this role is located

🏢 Summary: The Associate Director of Brand & Experience Strategy leads lifecycle communications and student experience design for university partners, shaping cross-channel recruitment strategies and messaging frameworks. The role combines brand, content, and UX strategy with partner-facing discovery, journey mapping, and performance analysis. It requires strong strategic execution, cross-functional collaboration, and data-driven decision-making in higher education marketing. 🗂️ Requirements: 3+ years of experience in marketing strategy, brand strategy, content strategy, engagement communications, or related field, Working understanding of cross-channel lifecycle communications and student recruitment journey, Experience leading or contributing to partner-facing strategy sessions, workshops, or discovery engagements, Ability to design and map cross-channel lifecycle communications (email, text, chat), Experience translating journey insights into actionable briefs for implementation teams, Strong analytical skills and ability to connect performance data to strategy, Excellent written and verbal communication skills, English fluency, Must reside in the United States and be legally authorized to work, Reliable high-speed internet and availability during core business hours 📃 Skills: CRM, MarketingAutomation, SEO, UX, EmailMarketing, SMS, Analytics, JourneyMapping, ContentStrategy, BrandStrategy 🏢 Description: About the Role: The Associate Director of Brand and Experience Strategy shapes how university partners engage prospective students across the full recruitment lifecycle. This role works across brand and messaging strategy, lifecycle communications, content strategy, and student experience design, pairing deep partner knowledge and cross-functional fluency. As a strategist, you will act as a consultative partner to university partners and internal teams, developing breadth across practice areas while building deeper expertise in one or more over time. You will contribute to strategic frameworks, execute against them independently, and bring strategic thinking to partner-facing work. Strategic Practice & Framework Contribution - Contribute to strategic practice areas such as event strategy, lifecycle communications, content strategy framework, messaging architecture, or UX/student experience design - Support the development, documentation, and continuous improvement of shared frameworks - Partner with cross-functional teams and subject matter experts to apply shared frameworks effectively - Maintain awareness of cross-portfolio patterns and surface insights to senior strategists - Stay current on market trends, student behavior, and higher education recruitment best practices Partner Engagement & Discovery - Develop familiarity with assigned university partners, programs, competitive landscape, and student audiences - Serve as a consistent second voice in partner relationships, providing strategic and cross-portfolio perspective - Participate in discovery engagements for new program launches and portfolio expansions - Contribute to and support facilitation of strategy sessions and workshops - Develop and deliver presentations articulating strategy and recommended tactics Lifecycle Communications & Student Experience Design - Lead the design and mapping of cross-channel lifecycle communications, including automated email and text journeys, recruitment communication cadences, chat scripts, and toolkits - Oversee journey mapping processes across recruitment and retention lifecycle - Translate journey insights into actionable briefs for implementation teams - Contribute to brand strategy, messaging frameworks, and student experience design Measurement & Visibility - Contribute to reporting on strategy performance, including content effectiveness and communication metrics - Use data and analytical reasoning to identify gaps and recommend improvements - Partner with analytics, SEO, and implementation teams to align performance data with strategic decisions Team and Organizational Contribution - Support peers and cross-functional collaborators in executing shared frameworks - Contribute to cross-functional initiatives such as campaign measurement frameworks and technology rollouts - Ensure strategic intent is maintained from discovery through implementation You have: - 3+ years of experience in marketing strategy, brand strategy, content strategy, engagement communications, or related field; higher education experience preferred - Demonstrated ability to work across multiple practice areas with depth in at least one - Working understanding of cross-channel lifecycle communications and student recruitment journey - Experience contributing to partner-facing strategy sessions, workshops, or discovery engagements - Comfort working in a matrixed environment - Excellent written and verbal communication skills - Strong analytical and problem-solving skills - English fluency Bonus Points: - Experience in brand strategy, UX, content strategy, sales enablement, or SEO - Familiarity with higher education enrollment tools and CRM or marketing automation platforms - Experience with competitive landscape analysis or program positioning - Comfort navigating ambiguity in evolving team structures Role Requirements: - Must reside in the continental United States near a major airport - Reliable high-speed internet and quiet workspace - Availability during core business hours (9 a.m. to 5 p.m.) - Legal authorization to live and work in the United States Benefits: - Work from NYC office or home office - 401(k) with company match and equity opportunities - Medical, dental, and vision insurance - Employer-paid life and disability insurance - Health Savings Account (HSA) and Flexible Spending Accounts (FSA) - Paid parental leave - 4 weeks paid vacation plus holidays and sick leave - Monthly mobile connectivity stipend - Annual education stipend - Employee assistance and wellness programs

🏢 Summary: Full-time onsite Associate Medical Director/Medical Director role focused on advancing RNAi-based cardiometabolic therapies from late-stage clinical research through regulatory submissions. The position involves leading clinical study design, safety monitoring, data interpretation, and cross-functional collaboration for cardiac, lipid, and obesity programs. 🗂️ Requirements: M.D. or MD/Ph.D., Research experience in pharmaceutical, biotechnology, or academic settings, Hands-on translational research experience, Understanding of drug development processes, Knowledge of Good Clinical Practices, Knowledge of FDA regulations and regulatory requirements, Ability to evaluate external scientific advice, Strong scientific and medical communication skills, Ability to work independently in a fast-paced team environment, Project management skills, Strong clinical, scientific, and technical skills, Valid work authorization in the country where the role is located 📃 Skills: RNAi, siRNA, GCP, FDA, NDA, MAA, IRB, Biometrics, ClinicalTrials, Regulatory, Pharmacology, Cardiology, Endocrinology 🏢 Description: Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing RNA interference (RNAi)-based therapies for genetically driven diseases. The Associate Medical Director/Medical Director will report to the head of cardiometabolic clinical development and will be instrumental in bringing new RNAi therapies to patients. This individual will collaborate with scientific and clinical teams to advance drugs from late-stage clinical research through NDA filings, with an initial focus on siRNA programs targeting cardiac and metabolic indications including lipids and obesity. This is a full-time onsite position based at the corporate headquarters in Pasadena, CA. Responsibilities - Support the conceptualization, design, development, execution, and communication of clinical studies across therapeutic areas - Act as a medical lead within cross-functional teams including medical, scientific, clinical, safety, program management, and regulatory staff - Communicate protocols and study information with clinical site investigators and staff - Interpret clinical trial data and communicate results accurately - Provide ongoing clinical monitoring including eligibility assessment, toxicity management, and drug safety surveillance - Contribute to IRB submissions, protocols, study reports, publications, and regulatory submissions including NDA/MAA filings - Provide scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management teams - Identify key opinion leaders and participate in advisory board meetings - Deliver scientific presentations at advisory boards and scientific meetings - Identify and evaluate medical needs and new applications of RNA interference therapies - Monitor developments in RNA interference across industry and academia - Support licensing activities and partner relationships Requirements - M.D. or MD/Ph.D. with research experience - Hands-on translational research experience in pharmaceutical, biotechnology, or academic environments - Understanding of the drug development process - Knowledge of Good Clinical Practices, FDA regulations, and regulatory requirements - Ability to evaluate expert scientific advice - Strong written and verbal scientific communication skills - Ability to work independently in a fast-paced team environment - Strong clinical, scientific, and technical skills - Strong interpersonal and collaboration skills - Sense of urgency with problem-solving initiative - Project management skills and results-oriented mindset Preferred - Fellowship training in cardiology or endocrinology - Research focused on lipids or obesity Benefits - Competitive salary and benefits package - California pay range: $260,000–$310,000 USD - Candidates must have valid authorization to work in the country where the role is located.

🏢 Summary: Leadership role responsible for driving data analytics strategy and integrating AI to enhance predictive capabilities, operational efficiency, and strategic decision-making in a highly regulated pharmaceutical environment. The position leads cross-functional analytics initiatives, ensures regulatory compliance, and manages a high-performing data team aligned with business goals. Focused on innovation and governance, the role leverages advanced analytics and AI to support organizational growth and performance. 🗂️ Requirements: Bachelor's degree in Data Science, Business Analytics, or related field, Minimum 5 years of experience in data analytics or related roles, At least 2 years of leadership experience, Proven experience leveraging AI in data analytics, Experience in a highly regulated industry, Strong knowledge of data governance and regulatory compliance, Proficiency in data analytics tools and AI-driven platforms 📃 Skills: AI, Analytics, DataScience, PredictiveAnalytics, DataGovernance, Compliance, ProjectManagement, Reporting, DataManagement 🏢 Description: Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we're redefining what's possible in personalized medicine and pharmaceutical manufacturing. We're proud to be recognized as one of Houston's fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025. Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we've created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that's transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let's transform healthcare together.POSITION SUMMARY The Manager, Data Analytics plays a crucial role in driving business impact through sophisticated data analysis and strategic insights. This position encompasses ownership of extensive data projects, leveraging AI to enhance speed, scale, quality, and decision-making. Aligned with Empower's growth in a 503A/503B environment, the role demands excellence in strategic thinking, execution rigor, and learning agility. This role is pivotal in aligning data analytics strategies with business goals, ensuring compliance, and fostering innovation in a highly regulated landscape. Candidates must demonstrate strong leadership capabilities and the ability to optimize AI as a transformative force multiplier, advancing Empower's competitive edge and operational efficiency. RESPONSIBILITIES Data Strategy AI Integration: Develop and implement data analytics strategies that integrate AI to enhance predictive analytics capabilities, improve data quality, and support strategic decision-making across the organization. Collaborate with cross-functional teams to ensure alignment with business objectives and regulatory requirements. Innovation Leadership: Lead the exploration and adoption of cutting-edge AI technologies to drive innovation in data analytics processes. Foster a culture of continuous improvement and learning within the analytics team to maintain competitive advantage in the industry. Strategic Alignment: Ensure data analytics initiatives align with Empower's business goals and regulatory standards. Utilize data-driven insights to inform strategic planning and operational decisions, contributing to the company's growth and compliance in a highly regulated sector. Team Leadership Mentorship and Development: Provide leadership and mentorship to the data analytics team, fostering a collaborative and high-performance environment. Encourage professional growth and development, ensuring the team possesses the skills necessary to meet evolving business needs. Performance Management: Oversee team performance, setting clear objectives and key results (OKRs) aligned with organizational goals. Implement performance metrics and feedback mechanisms to drive accountability and excellence in execution. Talent Acquisition: Participate in the recruitment and retention of top-tier analytics talent. Ensure the team's competencies align with the strategic demands of the business, cultivating a diverse and inclusive workplace culture. Operational Excellence Process Optimization: Optimize data analytics processes to improve efficiency and effectiveness, leveraging AI to streamline operations. Implement best practices and continuous improvement initiatives to enhance data analysis capabilities and outcomes. Resource Management: Manage analytics resources, ensuring efficient allocation of tools and technologies. Monitor budgetary constraints and leverage AI-driven solutions to maximize resource utilization and operational efficiency. Regulatory Compliance: Ensure data analytics practices comply with industry regulations and standards. Implement governance frameworks to maintain data integrity, security, and privacy, supporting Empower's commitment to compliance and ethical practices. Cross-Functional Collaboration Partnership Building: Establish and maintain strong relationships with key stakeholders across the organization. Collaborate with departments such as IT, finance, and operations to align data analytics projects with business priorities and strategic initiatives. Communication and Reporting: Effectively communicate data insights and analytics findings to non-technical audiences. Prepare and deliver executive-level reports and presentations that articulate the value and impact of analytics initiatives on business performance. Project Management: Lead cross-functional data analytics projects, ensuring timely delivery and alignment with business objectives. Utilize AI-driven project management tools to enhance collaboration, track progress, and optimize project outcomes. KNOWLEDGE AND SKILLS Proficient in data analytics tools and AI-driven platforms, with strong analytical and problem-solving skills. Exceptional leadership and team management abilities, fostering a culture of innovation and continuous improvement. Strong understanding of regulatory compliance within data management and analytics environments. Excellent communication and stakeholder management skills, with the ability to convey complex data insights effectively. EXPERIENCE AND QUALIFICATIONS Bachelor's degree in Data Science, Business Analytics, or related field; Master's preferred. Minimum of 5 years of experience in data analytics or related roles, with at least 2 years in a leadership position. Proven track record of leveraging AI to drive business innovation and enhance data analytics capabilities. Experience in a highly regulated industry, with a deep understanding of data governance and compliance. Key Competencies: Customer Focus: Builds trust through customer-centric solutions. Strategic AI: Guides responsible AI adoption and adaptation. Optimizes Work Processes: Drives efficiency with continuous improvement. Collaborates: Partners effectively to achieve shared goals. Resourcefulness: Secures and deploys resources efficiently. Manages Complexity: Simplifies and solves complex challenges. Ensures Accountability: Delivers on commitments with integrity. Situational Adaptability: Adjusts approach to shifting conditions. Communicates Effectively: Tailors messages to diverse audiences. Values: People: Empowering people defines who we are. Quality: Excellence in every product, every time. Service: Serving others is our highest purpose. Innovation: Advancing care through technology and discovery. Employee Benefits, Health and Wellness: We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/ Physical Requirements: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

🏢 Summary: Hybrid Data Analyst role focused on transforming and standardizing clinical study data into analysis-ready datasets, enabling cross-study consistency and reusability. The position involves data wrangling, anomaly detection, FAIR data improvements, and building reproducible workflows using Python, SQL, and AWS tools. The role requires close collaboration with stakeholders to translate ambiguous business questions into structured analytical outputs within a GDPR-compliant environment. 🗂️ Requirements: Proficiency in Python for data analysis and transformation, Proficiency in SQL for querying and validation, Experience with AWS environments including S3, Experience standardizing and harmonizing heterogeneous datasets, Ability to detect patterns, anomalies, and structural differences across datasets, Experience building reproducible data workflows, Experience with data visualization tools, Knowledge of GDPR-compliant data handling, Fluent English (spoken and written) 📃 Skills: Python, SQL, AWS, S3, PowerBI, GDPR, CDISC, SDTM, ADaM, SAS, MachineLearning, AI, LLM 🏢 Description: Data Analyst within Study Patient Operations About the project We are looking for a Data Analyst in collaboration with a global, science‑driven biopharmaceutical company that uses data and advanced analytics to accelerate the development of innovative therapies. As a Data Analyst in Study Patient Operations, you will transform diverse clinical study data into reliable, analysis‑ready datasets and support cross‑study standardisation and reusability. This role is ideal for someone who thrives in ambiguity, shows strong analytical curiosity, and proactively proposes structured solutions even with incomplete information. Work mode: hybrid — based in Warsaw, with one day per week on-site at the client’s office . Tasks Cross‑study data standardisation: Standardise and harmonise data from multiple studies with varying conventions to enable consistent cross‑study analysis. Pattern and anomaly detection: Identify patterns, discrepancies, anomalies, and structural differences across datasets and convert them into actionable mapping rules and validation checks. FAIR data improvement: Strengthen metadata, lineage, definitions, and data quality to enhance data accessibility and reusability, even when documentation is incomplete. Problem framing & stakeholder collaboration: Translate broad or ambiguous business questions into clear data requirements, analytical approaches, and defined pipeline outputs. Data wrangling & transformation: Extract, join, transform, and reconcile datasets using Python, SQL, and AWS‑based tools to support downstream analysis. Compliance, documentation & insight communication: Ensure GDPR‑aligned data handling, maintain audit‑ready documentation, and clearly communicate insights, limitations, and assumptions. Expectations Strong analytical problem‑solving skills in ambiguous contexts and ability to iterate toward clarity. Learning agility , with motivation to quickly understand new domains and clinical data standards. Standardisation mindset , with experience proposing consistent mappings across heterogeneous datasets. Pattern recognition ability across multiple datasets/studies. Proficiency in Python and SQL for analysis, validation, and reproducible workflows. Experience with AWS environments , especially S3 and analytical/querying tools. Data visualisation skills (Power BI or similar). Excellent communication and documentation abilities , especially explaining “what the data means.” Fluent in English (spoken and written) Beneficial Skills Familiarity with clinical trial standards (e.g., CDISC SDTM, ADaM ). Experience with SAS-formatted clinical datasets . Understanding of clinical study processes , privacy/consent principles, and patient data handling. Exposure to machine learning / AI / agentic tools . Interest or experience in LLM-based tooling , especially for metadata, documentation, or analytics workflows. We offer Ongoing support from a dedicated agent , taking care of your project continuity, client contact, necessary formalities, work comfort and development, Consultant Development Program – advice on growth planning based on the latest trends and market needs in IT, including consultations with agents and growth mentors, Access to 7N Learning & Development – a development and educational platform with webinars, a library of articles and industry reports, and regular invitations to one-time and recurring development events – technical, business, and lifestyle, Spectacular integration events , both for you (e.g., annual Kick-Off trip , Christmas parties, or Summer Olympics sports events) and for your loved ones (e.g., family picnics, movie premieres), Professional development not only during the project – you can get involved in knowledge transfer to others within the 7N Services offering directed at 7N clients, Relationships and access to the knowledge of the most experienced IT experts in the market – the average professional tenure of our consultants in Poland is over 10 years, A complete benefits package , including funding for medical care, life insurance, sports cards for you and your loved ones, as well as discounts in stores in Poland and abroad. About 7N Constantly searching for projects, difficult rate negotiations, lack of development support – sounds familiar? At 7N, you gain not only stability of contracts but also the personal involvement of a dedicated agent who ensures your professional comfort and continuous access to development initiatives. Our mission is to provide stable and rewarding collaborations that drive your success as an IT expert and the success of our clients. We build long-lasting relationships based on Scandinavian values and 30 years of experience creating IT solutions for over 200 organizations.

🏢 Summary: Senior medical communications role focused on scientific strategy, technical writing, client leadership, and team management across complex healthcare and pharmaceutical projects. The position involves developing evidence-based deliverables, leading client engagements, mentoring junior writers, and supporting business growth initiatives. 🗂️ Requirements: Advanced doctoral degree (PhD, MD, PharmD, or equivalent), 5–7 years in medical communications, Expertise in more than one therapeutic area, Strong scientific and editorial writing skills, Experience managing client and HCP relationships, Ability to review scientific content for accuracy and compliance, Experience mentoring and coaching junior writers, Ability to manage multiple deadlines under pressure, Knowledge of pharmaceutical industry standards and compliance 📃 Skills: Pharma, Compliance, Editorial, Research, Writing, Coaching, Mentoring, ProjectManagement, Communication, ScientificWriting 🏢 Description: A BOLDSCIENCE Associate Scientific Director (ASD) is pivotal in the Scientific Services senior team. They have excellent technical writing skills and broad medical communications experience. An ASD is a key day-to-day contact for the client and is viewed as a trusted partner. They respectfully challenge clients when needed and provide useful suggestions and appropriate recommendations. They can interpret the client's needs into strategic goals and translate them to the team for implementation into deliverables. They can utilize their experience to conceptualize and execute less well-defined and more strategic projects into a successful output with minimal input. An ASD has excellent communication skills and is adept at leading a small-to-medium-sized team, including resourcing, quality control, and processes. They ensure that all content developed is evidence-based, of the highest editorial quality, and meets the client's strategic objectives. They establish strong working relationships and actively collaborate with internal and client teams. They pride themselves in people management and their ability to coach and mentor their team to success, ensuring that the highest quality standards are met. Day-to-Day Responsibilities: Technical Writing: - Designs, develops, and reviews different types of materials across a wide range of project types for various audiences, including more complex, strategic deliverables (e.g., scientific platforms, communication plans, and workshops) from start to finish with minimal technical input from senior team members - Ensures that projects reflect a thorough understanding of clients' products strategies and communication objectives and that scientific statements are supported appropriately - Delivers client-ready work for review that is thoroughly researched, technically accurate, well written, presentable, and meets client objectives - Takes responsibility for the quality of the work by junior team members, ensuring that they are scientifically accurate, fully referenced, appropriate to the target audience, meet client objectives, and adhere to the time and budget allocated for the project - Provides constructive feedback and coaching to junior-level writers - Demonstrates a thorough understanding of the client brief; asks well-informed questions to ensure that all relevant information has been received and communicates the brief to the team Client & Project Management Skills: - Leads client meetings, including project kick-off, regular status, and ad hoc client and healthcare professional (HCP) calls - Builds strong client relationships with the confidence to push back and advise where necessary - Leads briefing calls and follow-up conversations with HCPs and subject matter experts - Collaborates with clients to make recommendations and provide advice - Plans weekly and long-term workload for the account team in collaboration with senior team members - Communicates and delegates briefs effectively, ensuring deliverables align with client strategic goals and quality standards - Ensures senior team members are updated on account activity and resourcing needs - Uses a forward-thinking approach to provide clients with fresh ideas Scientific Knowledge: - Detailed understanding of the therapeutic area and strategic needs across accounts - Ability to translate highly technical scientific data into accessible deliverables for different audiences New Business: - Participates in new business activities, including organic growth of existing accounts and requests for proposals - Develops sections of new business proposals that are well researched and accurate - Represents the scientific team on new business pitches - Identifies opportunities for organic client growth and new business opportunities Financial Management: - Monitors project recoverability and proactively manages project budgets while maintaining quality and client satisfaction - Monitors billability for self and direct reports - Completes timesheets accurately and on time People Management Skills: - Manages 1–3 direct reports effectively by providing constructive and actionable feedback - Provides regular feedback and guidance throughout projects - Mentors junior-level team members on skills and best practices - Oversees activities of junior colleagues to ensure quality standards are maintained - Contributes to training and development of the Scientific Services team Required Qualifications: - Advanced, doctoral-level degree (Ph.D., M.D., PharmD, etc.) - 5–7 years of experience within the medical communications industry - Expertise in more than one therapy area - Excellent scientific and editorial competency and communication skills - Experience building strong relationships with clients and HCPs - Ability to critically review deliverables for scientific accuracy and integrity - Experience coaching and mentoring junior-level writers - Proactive approach and enthusiasm for trying new things - Ability to work under pressure and manage multiple deadlines - In-depth knowledge of pharmaceutical industry standards and compliance

🏢 Summary: The offer is for a remote Data Analyst role within Study Patient Operations, focused on transforming diverse clinical study data into standardized, analysis-ready datasets. The position involves cross-study data harmonization, pattern and anomaly detection, data quality improvement, and building reproducible data pipelines in a regulated environment. The role requires close collaboration with stakeholders to translate ambiguous business questions into structured analytical solutions using modern data tools. 🗂️ Requirements: Proficiency in Python and SQL for data analysis and reproducible workflows, Experience with AWS environments, especially S3 and analytical/query tools, Experience in data standardization and harmonization across heterogeneous datasets, Ability to perform data wrangling, transformation, and validation, Experience in pattern and anomaly detection across multiple datasets, Knowledge of GDPR-compliant data handling and documentation practices, Ability to translate ambiguous business requirements into structured data solutions, Data visualization skills using BI tools, Fluent English (spoken and written) 📃 Skills: Python, SQL, AWS, S3, PowerBI, GDPR, CDISC, SDTM, ADaM, SAS 🏢 Description: Data Analyst within Study Patient Operations About the project We are looking for a Data Analyst in collaboration with a global, science‑driven biopharmaceutical company that uses data and advanced analytics to accelerate the development of innovative therapies. As a Data Analyst in Study Patient Operations, you will transform diverse clinical study data into reliable, analysis‑ready datasets and support cross‑study standardisation and reusability. This role is ideal for someone who thrives in ambiguity, shows strong analytical curiosity, and proactively proposes structured solutions even with incomplete information. Work mode: 100% remote (with one day per month on-site at the client’s office in Warsaw) Tasks Cross‑study data standardisation: Standardise and harmonise data from multiple studies with varying conventions to enable consistent cross‑study analysis. Pattern and anomaly detection: Identify patterns, discrepancies, anomalies, and structural differences across datasets and convert them into actionable mapping rules and validation checks. FAIR data improvement: Strengthen metadata, lineage, definitions, and data quality to enhance data accessibility and reusability, even when documentation is incomplete. Problem framing & stakeholder collaboration: Translate broad or ambiguous business questions into clear data requirements, analytical approaches, and defined pipeline outputs. Data wrangling & transformation: Extract, join, transform, and reconcile datasets using Python, SQL, and AWS‑based tools to support downstream analysis. Compliance, documentation & insight communication: Ensure GDPR‑aligned data handling, maintain audit‑ready documentation, and clearly communicate insights, limitations, and assumptions. Expectations Strong analytical problem‑solving skills in ambiguous contexts and ability to iterate toward clarity. Learning agility , with motivation to quickly understand new domains and clinical data standards. Standardisation mindset , with experience proposing consistent mappings across heterogeneous datasets. Pattern recognition ability across multiple datasets/studies. Proficiency in Python and SQL for analysis, validation, and reproducible workflows. Experience with AWS environments , especially S3 and analytical/querying tools. Data visualisation skills (Power BI or similar). Excellent communication and documentation abilities , especially explaining “what the data means.” Fluent in English (spoken and written) Beneficial Skills Familiarity with clinical trial standards (e.g., CDISC SDTM, ADaM ). Experience with SAS-formatted clinical datasets . Understanding of clinical study processes , privacy/consent principles, and patient data handling. Exposure to machine learning / AI / agentic tools . Interest or experience in LLM-based tooling , especially for metadata, documentation, or analytics workflows. We offer Ongoing support from a dedicated agent , taking care of your project continuity, client contact, necessary formalities, work comfort and development, Consultant Development Program – advice on growth planning based on the latest trends and market needs in IT, including consultations with agents and growth mentors, Access to 7N Learning & Development – a development and educational platform with webinars, a library of articles and industry reports, and regular invitations to one-time and recurring development events – technical, business, and lifestyle, Spectacular integration events , both for you (e.g., annual Kick-Off trip , Christmas parties, or Summer Olympics sports events) and for your loved ones (e.g., family picnics, movie premieres), Professional development not only during the project – you can get involved in knowledge transfer to others within the 7N Services offering directed at 7N clients, Relationships and access to the knowledge of the most experienced IT experts in the market – the average professional tenure of our consultants in Poland is over 10 years, A complete benefits package , including funding for medical care, life insurance, sports cards for you and your loved ones, as well as discounts in stores in Poland and abroad. About 7N Constantly searching for projects, difficult rate negotiations, lack of development support – sounds familiar? At 7N, you gain not only stability of contracts but also the personal involvement of a dedicated agent who ensures your professional comfort and continuous access to development initiatives. Our mission is to provide stable and rewarding collaborations that drive your success as an IT expert and the success of our clients. We build long-lasting relationships based on Scandinavian values and 30 years of experience creating IT solutions for over 200 organizations.