<p>Ensure program team compliance with SOPs and departmental standards. Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials Prepares statistical analysis plans 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 resource planning/allocation and timeline management across their clinical development program, and recruiting, retaining, managing, and mentoring biostatisticians Manages internal and vendor statistical and programming support. Ph.D. in Statistics or Biostatistics or Equivalent with at least 8-10 years pharmaceutical statistics experience (preferred), or Masters in Statistics or Biostatistics or Equivalent with at least 10-12 years pharmaceutical statistics experience Excellent written and oral communication and presentation skills Experience programming in SAS Interest in and basic understanding of biology and biological processes, including RNAi Experience in clinical development through Phase 3 (NDA submission). Understanding of ICH GCP as well as general knowledge of industry best practices and standards Proficiency in R programming language Experience with CDISC, including SDTM, ADaM, CDASH Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities Experience in drug development for rare genetic diseases Experience with DMPK endpoints and analyses Experience designing and conducting adaptive trials Experience with Bayesian and/or adaptive clinical trial design and analysis</p>