Executive Director, Biostatistics
Alnylam Pharmaceuticals
July 02, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Provide strategic statistical leadership across a portfolio of clinical development programs, ensuring rigorous and innovative quantitative approaches throughout all phases.
- Lead the development and implementation of statistical strategies across programs, including clinical trial designs, endpoint strategies, and regulatory strategies.
- Lead statistical strategy for global regulatory submissions, including NDA filings and major regulatory interactions; represent Biostatistics with global regulatory authorities (e.g., FDA, EMA, PMDA) and external stakeholders.
- Review and ensure the quality and scientific rigor of key statistical deliverables and study documents.
- Evaluate, apply, and advance innovative statistical approaches and emerging quantitative methodologies, including advanced analytics and data science tools.
- Lead and develop a team of statisticians, providing mentorship, scientific guidance, and review.
- Contribute to departmental strategy and advance statistical standards, best practices, and innovation.
Qualifications:
- PhD in Statistics/Biostatistics or related field with 15+ years in pharmaceutical/biotechnology drug development, or MS with 18+ years.
- Demonstrated leadership of statistical strategy across multiple clinical development programs and phases.
- Expertise in clinical trial design and statistical methodologies, including adaptive designs, Bayesian methods, or simulation-guided decision-making.
- Experience leading major global regulatory submissions (e.g., NDA/BLA) and interactions with FDA/EMA/PMDA.
- People management experience developing high-performing teams and managing resources across programs.
Compensation/Benefits:
- U.S. pay range: $301,800.00 - $408,200.00.
- Eligible for annual short-term incentive and annual long-term incentive awards.
- Medical, dental, vision; life/disability insurance; lifestyle reimbursement; flexible spending/health savings; 401(k) with company match; paid time off, wellness days, holidays, recharge breaks; family resources and leave.
- Provide strategic statistical leadership across a portfolio of clinical development programs, ensuring rigorous and innovative quantitative approaches throughout all phases.
- Lead the development and implementation of statistical strategies across programs, including clinical trial designs, endpoint strategies, and regulatory strategies.
- Lead statistical strategy for global regulatory submissions, including NDA filings and major regulatory interactions; represent Biostatistics with global regulatory authorities (e.g., FDA, EMA, PMDA) and external stakeholders.
- Review and ensure the quality and scientific rigor of key statistical deliverables and study documents.
- Evaluate, apply, and advance innovative statistical approaches and emerging quantitative methodologies, including advanced analytics and data science tools.
- Lead and develop a team of statisticians, providing mentorship, scientific guidance, and review.
- Contribute to departmental strategy and advance statistical standards, best practices, and innovation.
Qualifications:
- PhD in Statistics/Biostatistics or related field with 15+ years in pharmaceutical/biotechnology drug development, or MS with 18+ years.
- Demonstrated leadership of statistical strategy across multiple clinical development programs and phases.
- Expertise in clinical trial design and statistical methodologies, including adaptive designs, Bayesian methods, or simulation-guided decision-making.
- Experience leading major global regulatory submissions (e.g., NDA/BLA) and interactions with FDA/EMA/PMDA.
- People management experience developing high-performing teams and managing resources across programs.
Compensation/Benefits:
- U.S. pay range: $301,800.00 - $408,200.00.
- Eligible for annual short-term incentive and annual long-term incentive awards.
- Medical, dental, vision; life/disability insurance; lifestyle reimbursement; flexible spending/health savings; 401(k) with company match; paid time off, wellness days, holidays, recharge breaks; family resources and leave.