Overview In this role you lead biostatistics for large, late-phase programs, shaping trial design and regulatory submissions. You collaborate cross-functionally to ensure high-quality statistical analyses and clear interpretation of results for manuscripts and regulatory documents. You drive strategic thinking within Clinical Development and oversee worldwide regulatory support. Your work defines how statistics enable impact in RNAi therapeutics at Alnylam.
Compensation / Benefits- medical, dental, and vision coverage
- life and disability insurance
- 401(k) with generous company match
- wellness days and paid time off
- holidays and recharge breaks
- family resources and leave
Responsibilities- Shape strategic direction for clinical programs and the Clinical Development Plan
- Lead large and/or complex late-phase program(s) in biostatistics
- Foster teamwork, quality, and innovation across program teams
- Collaborate with Clinical Development, Regulatory, and Clinical Operations to design innovative trials
- Author statistical sections in protocols and SAPs
- Review and approve stratification and randomization strategies
- Coordinate with Data Management and Clinical Operations on eCRF design
- Provide statistical guidance during ongoing trials
- Collaborate with Statistical Programmers on trial data summaries and analyses
- Write ADaM and ad hoc analysis specifications
- Interpret and communicate trial results for regulatory submissions and manuscripts
- Contribute to study reports and regulatory documents (DSURs, Briefing Documents)
- Lead biostatistics support for worldwide regulatory submissions
- Represent Alnylam in regulator and stakeholder meetings
- Contribute to scientific articles summarizing trial data
- Consult with Research, Preclinical, Clinical Pharmacology, Medical Affairs and Commercial teams on statistical questions
- Oversee timeline management across the clinical development program
Key requirements- Ph.D. in Statistics or Biostatistics or equivalent with 8-10 years of pharmaceutical statistics experience
- Excellent written and oral communication and presentation skills
- Experience designing and supporting late-phase (Phase 2/3) studies
- Experience conducting clinical trial simulations to evaluate design options and operating characteristics
- Interest in biology and biological processes, including RNAi
- Experience with Bayesian and adaptive clinical trial design
- Experience leading or supporting NDA and MAA submissions
- Proficiency in SAS and R
- Experience representing sponsors in meetings with US FDA and international regulatory authorities
- leadership and team building
- clear and persuasive communication
- cross-functional collaboration
- Bayesian and adaptive trial design
- late-phase trial design (Phase 2/3)
- clinical trial simulations
