Sr. Manager/ Associate Director, Statistical Programming

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.