Director, Biostatistics — Lead Late-Phase Clinical Programs

Alnylam Pharmaceuticals, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. seeks a Director of Biostatistics to guide statistical activities for late-phase clinical development, from trial design to regulatory submissions.

The role requires leadership across programs, collaboration with regulatory and clinical teams, and delivering high-quality analyses for diverse regulatory bodies and publications. The ideal candidate holds a PhD in Statistics or Biostatistics with extensive pharmaceutical experience, strong communication skills, and

Qualifications

• Ph.D. in Statistics or Biostatistics with at least 8–10 years pharmaceutical statistics experience.
• Excellent written and oral communication and presentation skills.
• Experience designing and supporting late-phase (Phase 2/3) clinical studies.
• Experience conducting clinical trial simulations to evaluate design options.
• Interest in biology and RNAi biology.

Responsibilities

• Lead statistical activities for large/complex late-phase programs.
• Design innovative clinical trials and write protocols/statistical analysis plans.
• Interpret analyses and support regulatory submissions and manuscripts.
• Collaborate with Regulatory, Clinical Development, Data Management, and other areas.

Skills

Statistical leadership

Late-phase design

Clinical trial simulations

Regulatory interactions

Cross-functional collaboration

Education

PhD in Statistics or Biostatistics

Tools

SAS

R

Job description

Alnylam Pharmaceuticals, Inc. seeks a Director of Biostatistics to guide statistical activities for late-phase clinical development, from trial design to regulatory submissions.

The role requires leadership across programs, collaboration with regulatory and clinical teams, and delivering high-quality analyses for diverse regulatory bodies and publications. The ideal candidate holds a PhD in Statistics or Biostatistics with extensive pharmaceutical experience, strong communication skills, and