Associate Director, Biostatistics

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. Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders Contributes to scientific articles, summarizing data collected in Alnylam trials. Participates in other activities and meetings to support Biostatistics and the Ph.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience. Excellent written and oral communication and presentation skills. 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 practices and standards. Proficiency in R programming language and other statistical software, including EAST. Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities. LI-LR1

Biopharmaceutical company pioneering RNA interference (RNAi) therapeutics for rare genetic, cardiometabolic, and CNS diseases. Headquartered in Cambridge, MA.

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