Director, Biostatistics

Contribute to strategic thinking and Clinical Development Plan (CDP) development. Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs Provides statistical guidance on conduct of ongoing trials Collaborates with Statistical Programmers on summary and analysis of trial data. Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc. Contributes to scientific articles, summarizing data collected in Alnylam trials Responsible for timeline management across their clinical development program Ph.D. in Statistics or Biostatistics or Equivalent with at least 8-10 years pharmaceutical statistics experience (preferred) 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, operating characteristics, and decision criteria Interest in and basic understanding of biology and biological processes, including RNAi Experience with Bayesian and adaptive clinical trial design Experience leading or supporting NDA and MAA submission Proficiency in SAS and R programming language Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities