Director, Biostatistics — Late-Phase Trials & Submissions

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 213,000 - 288,000; Full time

Benefits offered by this job

Medical, dental, and vision

Life and disability insurance

401(k) with company match

Paid time off and holidays

Job summary

Alnylam Pharmaceuticals seeks a Director of Biostatistics to provide leadership for late-phase programs, design innovative trials, and guide regulatory submissions. You will author SAPs, ensure quality of analyses, and collaborate across Clinical Development, Regulatory, and Operations.

The role requires a Ph.D. in Statistics or Biostatistics with 8–10 years of pharma statistics experience, strong communication, and expertise in Bayesian/adaptive designs, SAS and R, and NDA/MAA submissions.

Qualifications

• PhD in Statistics/Biostatistics or equivalent required.
• 8–10 years pharmaceutical statistics experience.
• Experience leading or supporting NDA/MAA submissions and late-phase trials.

Responsibilities

• Lead large and/or complex late-phase clinical development programs.
• Author statistical sections of protocols and SAPs.
• Provide statistical guidance across ongoing trials and regulatory submissions.
• Collaborate with cross-functional teams and regulators; represent sponsors in meetings.
• Contributes to regulatory documents and scientific articles.

Skills

Communication skills

Late-phase trial design

Bayesian and adaptive designs

SAS and R programming

Regulatory interactions

Education

Ph.D. in Statistics or Biostatistics or Equivalent

Tools

SAS

R

Job description

Alnylam Pharmaceuticals seeks a Director of Biostatistics to provide leadership for late-phase programs, design innovative trials, and guide regulatory submissions. You will author SAPs, ensure quality of analyses, and collaborate across Clinical Development, Regulatory, and Operations.

The role requires a Ph.D. in Statistics or Biostatistics with 8–10 years of pharma statistics experience, strong communication, and expertise in Bayesian/adaptive designs, SAS and R, and NDA/MAA submissions.