Associate Director, Biostatistics

Alnylam Pharmaceuticals seeks an Associate Director of Biostatistics responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

Key Responsibilities

• Represent biostatistics at cross-functional team meetings to drive clinical development
• Collaborate with Clinical Development, Regulatory, and Clinical Operations to design clinical trials
• Write statistical sections of clinical trial protocols
• Prepare statistical analysis plans
• Collaborate with Statistical Programmers on summary and analysis of trial data; write ADS and ad hoc analysis specifications
• Contribute to clinical study reports and regulatory documents (DSURs, Briefing Documents)
• Represent Alnylam in meetings with regulators, KOLs, and partners
• Manage CRO statistical and programming support

Required Qualifications

• PhD in Biostatistics or Statistics with 7+ years pharmaceutical experience; or MS with 10+ years
• Excellent communication and presentation skills
• Experience programming in SAS
• Interest in biology and biological processes, including RNAi

Desired Experience

• Clinical development through Phase 3 (NDA submission)
• Experience as lead statistician for a compound
• Proficiency in R and EAST
• CDISC experience (SDTM, ADaM, CDASH)
• Adaptive trial design experience
• FDA and international regulatory authority interaction

Virtual role. Salary: $185,300 - $250,700