Director, Biostatistics
Alnylam Pharmaceuticals
June 25, 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 program(s).
- 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 with Data Management, Clinical Development, and Clinical Operations.
- Provide statistical guidance on conduct of ongoing trials.
- Collaborate with Statistical Programmers on trial data summary/analysis; write ADaM and ad hoc analysis specifications.
- Interpret and communicate 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; consult with Research, Preclinical, Clinical Pharmacology, Medical Affairs, and Commercial on statistical questions.
- Manage timelines across the clinical development program.
Qualifications:
- Ph.D. in Statistics or Biostatistics (or equivalent) with 8–10+ years pharmaceutical statistics experience (preferred).
- Excellent written/oral communication and presentation skills.
- Experience designing/supporting late-phase (Phase 2/3) clinical studies.
- Experience conducting clinical trial simulations to evaluate design options and decision criteria.
- Interest in/basic understanding of biology and 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 regulatory authorities.
Benefits (if applicable): comprehensive medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources/leave.
- Contribute to strategic thinking and Clinical Development Plan (CDP) development.
- Lead large and/or complex late-phase clinical development program(s).
- 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 with Data Management, Clinical Development, and Clinical Operations.
- Provide statistical guidance on conduct of ongoing trials.
- Collaborate with Statistical Programmers on trial data summary/analysis; write ADaM and ad hoc analysis specifications.
- Interpret and communicate 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; consult with Research, Preclinical, Clinical Pharmacology, Medical Affairs, and Commercial on statistical questions.
- Manage timelines across the clinical development program.
Qualifications:
- Ph.D. in Statistics or Biostatistics (or equivalent) with 8–10+ years pharmaceutical statistics experience (preferred).
- Excellent written/oral communication and presentation skills.
- Experience designing/supporting late-phase (Phase 2/3) clinical studies.
- Experience conducting clinical trial simulations to evaluate design options and decision criteria.
- Interest in/basic understanding of biology and 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 regulatory authorities.
Benefits (if applicable): comprehensive medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, family resources/leave.