Associate Director, Biostatistics Overview:
The Associate Director, Biostatistics is responsible for statistical activities supporting clinical trials, including trial design, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting clinical trial data analyses.
Key Responsibilities:
Represent biostatistics in cross-functional team meetings to support clinical development and contribute to development plans.
Collaborate with Clinical Development, Regulatory, and Clinical Operations teams to design clinical trials.
Write statistical sections of protocols and consult with internal and external experts.
Contribute to or prepare statistical analysis plans.
Collaborate on the design of eCRFs with Data Management, Clinical Development, and Clinical Operations.
Provide statistical guidance during ongoing trials.
Work with Statistical Programmers on data analysis and summaries.
Write analysis specifications and contribute to regulatory documents such as clinical study reports, DSURs, and briefing documents.
Represent Alnylam in meetings with regulators, KOLs, partners, and stakeholders.
Contribute to scientific publications based on trial data.
Participate in activities supporting Biostatistics and the Development Team.
Consult with Research & Preclinical colleagues on statistical questions.
Manage CRO support for statistical and programming services.
Qualifications:
Ph.D. in Biostatistics, Statistics, or equivalent with ≥7 years of pharmaceutical biostatistics experience, or MS with ≥10 years relevant experience.
Excellent communication and presentation skills.
Proficiency in SAS programming.
Interest in biology and biological processes, including RNAi.
Desired Experience:
Experience in clinical development through Phase 3 and NDA submission.
Lead statistician experience for a compound.
Understanding of ICH GCP and industry standards.
Proficiency in R, EAST, and experience with CDISC standards.
Experience with FDA and international regulatory interactions.
Experience designing adaptive trials.
About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) pioneers RNA interference (RNAi) therapeutics, transforming genetic disease treatment since 2002, based on Nobel-winning science.
Our culture: Our people-first culture is driven by values of innovation, openness, urgency, excellence, and inclusivity. Recognized globally as a top employer, we foster a diverse environment where employees can thrive and bring groundbreaking medicines to patients. We are committed to equal opportunity and an inclusive workplace.
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