Job Description

Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials. Contributes to or 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. Participates in other activities and meetings to support Biostatistics and the Development Team as needed. Manages CRO statistical and programming support. Ph.D. in Biostatistics or Statistics or Equivalent with proven pharmaceutical biostatistics experience; or MS with at least 10 years relevant 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). Experience as lead statistician for a compound Understanding of ICH GCP as well as general knowledge of industry practices and standards. Proficiency in R programming language and other statistical software, including EAST. Experience with CDISC, including SDTM, ADaM, CDASH. Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities. Experience designing and conducting adaptive trials.