Sr. Manager/ Associate Director, Biostatistics

Position Summary

Senior Manager / Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs. This individual will serve as the lead biostatistician for one or more clinical development programs and will partner closely with Clinical Development, Medical Affairs, Data Management, Statistical Programming, Regulatory Affairs, and external partners to ensure the delivery of high-quality statistical strategy, analyses, and regulatory submissions.

The successful candidate will contribute to study design, protocol development, analysis planning, interpretation of clinical data, regulatory interactions, and evidence generation activities that support development, registration, and lifecycle management of programs. This role offers the opportunity to influence development strategy, advance innovative statistical methodologies, and contribute to regulatory and business decision-making.

Essential Duties and Responsibilities

Statistical Leadership & Clinical Development

• Lead the biostatistics strategy for one or more clinical development programs and studies.
• Serve as the statistical representative on cross-functional study teams, Clinical Development Teams, and governance committees.
• Collaborate with Clinical Development and Medical teams to design clinical studies aligned with program objectives, regulatory expectations, and business needs.
• Provide strategic input into clinical development plans, including study design, endpoint selection, sample size determination, interim analyses, and decision criteria.
• Identify potential statistical, operational, or scientific challenges and proactively develop solutions.
• Evaluate and implement innovative statistical methodologies to enhance development strategies and study efficiency.
• Support quantitative decision-making, including benefit-risk assessments, probability of technical success analyses, and Go/No-Go evaluations.

Study Design, Analysis & Reporting

• Author and/or review statistical sections of protocols, statistical analysis plans (SAPs), data review plans, and study reports.
• Develop and/or oversee analysis strategies, including tables, listings, and figures (TLFs), ensuring methodological rigor and regulatory compliance.
• Ensure timely delivery and quality of statistical analyses for interim reviews, final analyses, integrated summaries, and regulatory submissions.
• Interpret study results and effectively communicate findings to technical and non-technical audiences.
• Prepare and review abstracts, posters, manuscripts, presentations, and scientific publications.

Regulatory & External Interactions

• Contribute to regulatory strategies and support global submissions.
• Represent Biostatistics during interactions with health authorities, including FDA, EMA, PMDA, and other regulatory agencies, as appropriate.
• Support responses to regulatory questions related to study design, analysis methodologies, and interpretation of results.
• Ensure statistical deliverables meet applicable ICH, FDA, EMA, and other global regulatory requirements.

Medical Affairs, HEOR & Evidence Generation

• Provide statistical leadership for post-marketing studies, observational research, registry studies, real-world evidence initiatives, and outcomes research activities, as applicable.
• Support evidence generation strategies that address clinical, scientific, payer, and market access objectives.
• Collaborate with cross-functional partners to identify evidence gaps and develop analytical approaches to address unmet evidence needs.
• Contribute statistical expertise to publications, scientific communications, and evidence dissemination activities.

Vendor Oversight & Operational Excellence

• Oversee CROs, functional service providers, and external statistical vendors to ensure high-quality deliverables and adherence to timelines.
• Collaborate with Statistical Programming and Data Management to ensure data quality and efficient execution of analyses.
• Support departmental initiatives focused on process improvement, innovation, quality standards, and inspection readiness.
• Contribute to the development and maintenance of statistical standards, procedures, and best practices.

Required Education and Experience

Sr Manager:

• Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 4 years of pharmaceutical, biotechnology, or clinical research experience; or M.S. with a minimum of 6 years of experience.

Associate Director:

• Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 6 years of relevant pharmaceutical industry experience; or M.S. with a minimum of 8 years of experience.
• Demonstrated experience providing statistical leadership for clinical development programs and clinical trials.
• Strong knowledge of clinical trial methodology, study design, statistical analysis, and regulatory requirements.
• Experience supporting regulatory submissions and health authority interactions.
• Experience leading cross-functional teams and influencing development strategies.
• Expertise in statistical methods applicable to clinical development, including adaptive designs, longitudinal analyses, survival analyses, and integrated analyses.
• Experience overseeing CROs and external statistical vendors.
• Proficiency in SAS and/or R.
• Strong understanding of ICH, FDA, EMA, and other global regulatory guidance.
• Experience with real-world evidence, observational studies, HEOR, or post-marketing research is a plus.
• Experience in immunology, inflammation, autoimmune disease, or related therapeutic areas is preferred.