Executive Director, Biostatistics

Alnylam Pharmaceuticals

8d • Hybrid

About The Position

At Alnylam, the Executive Director, Biostatistics is a senior scientific leader responsible for developing and driving statistical strategy across clinical development programs. This role provides strategic leadership in statistical methodology, trial design, regulatory strategy, and quantitative insights that support decision‑making from early development through registration. The Executive Director leads a team of statisticians and works closely with cross‑functional leaders to ensure rigorous and innovative quantitative approaches to drug development. This position reports to the Head of Biostatistics within the Quantitative Science organization.
This position is hybrid onsite and remote working and will be primarily located at Cambridge or Philadelphia.

Requirements

• PhD in Statistics, Biostatistics, or a related quantitative discipline with 15+ years of relevant experience in pharmaceutical or biotechnology drug development; or MS with 18+ years of relevant experience.
• Demonstrated leadership of statistical strategy across multiple clinical development programs and phases of development.
• Expertise in clinical trial design and statistical methodologies supporting drug development, including the application of innovative approaches such as adaptive designs, Bayesian methods, or simulation-guided decision-making.
• Experience leading major global regulatory submissions (e.g., NDA/BLA) and interactions with health authorities such as FDA, EMA, and PMDA.
• Experience with people management, particularly in developing high-performing teams and managing resources across programs.

Responsibilities

• Provide strategic statistical leadership across a portfolio of clinical development programs, ensuring rigorous and innovative quantitative approaches throughout all phases of drug development.
• Lead the development and implementation of statistical strategies across programs, including clinical trial designs, endpoint strategies, and regulatory strategies, partnering with Clinical Development and cross-functional leaders to shape development plans.
• Lead statistical strategy for global regulatory submissions, including NDA filings and major regulatory interactions, and represent Biostatistics in engagements with global regulatory authorities (e.g., FDA, EMA, PMDA) and external scientific stakeholders.
• Review and ensure the quality and scientific rigor of key statistical deliverables and study documents across development programs.
• Evaluate, apply, and advance innovative statistical approaches and emerging quantitative methodologies, including advanced analytics and data science tools, to enhance development and decision-making.
• Lead and develop a team of statisticians, providing mentorship, scientific guidance, and review of statistical work to ensure high-quality support across development programs.
• Contribute to departmental strategy and advance statistical standards, best practices, and innovation within the Biostatistics and Quantitative Science organization.

Benefits

• We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match.
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees