Senior Director, Biostatistics
About The Position
Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: The Senior Director of Biostatistics acts as the statistical indication lead, providing strategic oversight for clinical development programs across one or multiple therapeutic areas. The Senior Director serves as the functional Biostatistics Therapeutic Area Lead and has direct leadership and accountability for biostatisticians aligned to the assigned therapeutic area. The role is accountable for the scientific rigor, strategic direction, and operational excellence of all biostatistics activities across assigned programs. The Senior Director sets and drives the therapeutic area strategy in alignment with clinical and regulatory objectives, ensuring high-quality design, analysis, interpretation, and reporting of clinical trial data. The role is accountable for the biostatistics components of regulatory submissions, including briefing documents, responses to agency questions, and NDA/BLA/MAA filings. This leader manages and develops a team of biostatisticians, including organizational design, resource planning, performance management, and budget oversight. The Senior Director also contributes to the biometrics strategy by advancing standards, methodologies, systems, and innovation across programs
Requirements
- PhD in Statistics, Biostatistics or Mathematics with a minimum of 10 years (minimum 15 years for master’s degree) of post-graduate experience in pharmaceutical clinical development
- Deep expertise in statistical principles, clinical trial methodology, and regulatory expectations
- Extensive experience in supporting global regulatory submissions and agency interactions
- Demonstrated ability to develop innovative and practical statistical solutions to complex development challenges
- Comprehensive understanding of the clinical development lifecycle and the strategic role of biostatistics
- Strong effective communication skills with the ability to translate complex statistical concepts into clear business implications
- Proven ability to manage multiple complex projects and shifting priorities in a fast paced environment
- Demonstrated leadership in strategic planning, organizational design, conflict resolution, and cross-functional collaboration
- Strong people leadership skills with track record of building high performing teams and developing future leaders
Responsibilities
- Provide strategic statistical leadership across assigned therapeutic areas, ensuring scientifically sound and operationally efficient execution of clinical development programs
- Lead and align biostatisticians supporting the assigned therapeutic area, establishing priorities, ensuring consistent scientific standards, and driving execution across programs
- Develop and implement organizational and staffing strategies to support portfolio needs and ensure high quality and on time completion of all deliverables
- Contributes to clinical development plans, regulatory strategies, and life cycle planning to optimize program success
- Serve as the senior statistical advisor to cross-fuctional leadership and senior management
- Represent Biostatistics in regulatory interactions, corporate partnerships, and CRO oversight
- Lead, mentor, and develop Biostatistics staff, fostering a culture of scientific rigor, accountability, and continuous improvement
- Advance departmental standards, governance, and innovative statistical methodologies across programs
- Partner cross-functionally with Clinical Development, Clinical Pharmacology, Regulatory, Data Management, and other functions to ensure aligned development strategies
Benefits
- Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more!
- Visit https://apellis.com/careers/benefits/ to learn more.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
