Director, Biostatistics

Alnylam Pharmaceuticals seeks a Director of Biostatistics to provide leadership and guidance for large and/or complex late phase clinical development programs. Responsible for statistical activities including designing innovative clinical trials, authoring statistical sections of protocols, and leading biostatistics support for worldwide regulatory submissions.

Key Responsibilities

• Contribute to strategic thinking and Clinical Development Plan (CDP) development
• Lead large and/or complex late phase clinical development programs
• Design innovative clinical trials in collaboration with Clinical Development, Regulatory, and Clinical Operations
• Author statistical sections of clinical trial protocols and statistical analysis plans
• Interpret and communicate results of statistical analysis for regulatory submissions and manuscripts
• Lead biostatistics support for worldwide regulatory submissions
• Represent Alnylam in meetings with regulators, Key Opinion Leaders, and partners
• Collaborate with Statistical Programmers on summary and analysis of trial data; write ADaM and ad hoc analysis specifications

Required Qualifications

• PhD in Statistics or Biostatistics with 8-10 years pharmaceutical statistics experience (preferred)
• Experience designing and supporting late-phase (Phase 2/3) clinical studies
• Experience conducting clinical trial simulations to evaluate design options and operating characteristics
• Interest in and understanding of biology and biological processes, including RNAi

Preferred Experience

• Bayesian and adaptive clinical trial design
• Leading or supporting NDA and MAA submissions
• Proficiency in SAS and R
• Representing sponsors in FDA and international regulatory authority meetings

Salary: $212,500 - $287,500