Director, Biostatistics
Alnylam Pharmaceuticals
August 07, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Contribute to strategic thinking and Clinical Development Plan (CDP) development.
- Lead large and/or complex late-phase clinical development programs.
- Collaborate with Clinical Development, Regulatory, and Clinical Operations to design innovative clinical trials.
- Author statistical sections of clinical trial protocols and statistical analysis plans.
- Review and approve stratification/randomization schema.
- Collaborate on design of eCRFs.
- Provide statistical guidance on conduct of ongoing trials.
- Partner with Statistical Programmers on trial data summary and analysis; write ADaM and ad hoc analysis specifications.
- Interpret and communicate statistical results in support of regulatory submissions and manuscripts.
- Contribute to clinical study reports and regulatory documents (e.g., DSURs, briefing documents).
- Lead biostatistics support for worldwide regulatory submissions.
- Represent the company in meetings with regulators, KOLs, partners, and stakeholders.
- Contribute to scientific articles and consult cross-functional teams on statistical questions.
- Responsible for timeline management across the clinical development program.
Qualifications:
- Ph.D. in Statistics/Biostatistics (or equivalent) with 8–10+ years pharmaceutical statistics experience (preferred).
- Excellent written/oral communication and presentation skills.
- Experience designing and supporting late-phase (Phase 2/3) studies.
- Experience conducting clinical trial simulations.
- Interest in and basic understanding of biology/biological processes, including RNAi.
Experience/Skills:
- Bayesian and adaptive clinical trial design.
- Experience leading/supporting NDA and MAA submissions.
- Proficiency in SAS and R.
- Experience representing sponsors with US FDA and international regulators.
Benefits/Compensation:
- U.S. Pay Range: $212,500.00 - $287,500.00; eligible for annual short-term incentive and annual long-term incentive.
- Medical, dental, vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources and leave.
- Learn more: https://www.alnylam.com/careers
- Contribute to strategic thinking and Clinical Development Plan (CDP) development.
- Lead large and/or complex late-phase clinical development programs.
- Collaborate with Clinical Development, Regulatory, and Clinical Operations to design innovative clinical trials.
- Author statistical sections of clinical trial protocols and statistical analysis plans.
- Review and approve stratification/randomization schema.
- Collaborate on design of eCRFs.
- Provide statistical guidance on conduct of ongoing trials.
- Partner with Statistical Programmers on trial data summary and analysis; write ADaM and ad hoc analysis specifications.
- Interpret and communicate statistical results in support of regulatory submissions and manuscripts.
- Contribute to clinical study reports and regulatory documents (e.g., DSURs, briefing documents).
- Lead biostatistics support for worldwide regulatory submissions.
- Represent the company in meetings with regulators, KOLs, partners, and stakeholders.
- Contribute to scientific articles and consult cross-functional teams on statistical questions.
- Responsible for timeline management across the clinical development program.
Qualifications:
- Ph.D. in Statistics/Biostatistics (or equivalent) with 8–10+ years pharmaceutical statistics experience (preferred).
- Excellent written/oral communication and presentation skills.
- Experience designing and supporting late-phase (Phase 2/3) studies.
- Experience conducting clinical trial simulations.
- Interest in and basic understanding of biology/biological processes, including RNAi.
Experience/Skills:
- Bayesian and adaptive clinical trial design.
- Experience leading/supporting NDA and MAA submissions.
- Proficiency in SAS and R.
- Experience representing sponsors with US FDA and international regulators.
Benefits/Compensation:
- U.S. Pay Range: $212,500.00 - $287,500.00; eligible for annual short-term incentive and annual long-term incentive.
- Medical, dental, vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources and leave.
- Learn more: https://www.alnylam.com/careers