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-AB1 #LI-Hybrid U.S. Pay Range $185,300.00 - $250,700.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

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

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