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Associate Director, CMC Statistician at Vaxcyte - ApplyBlast

Associate Director, CMC Statistician

Vaxcyte

4 months ago

3.9 on Glassdoor

Remote

Full Time

Director

0 applicants

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About this role

The Associate Director, CMC Statistician will lead statistical efforts for vaccine specification setting and justification across late-stage development, regulatory submissions, and commercial lifecycle. This role collaborates with cross‑functional teams including Process Development, MSAT, Stability, Quality, Regulatory Affairs, and Manufacturing to develop data‑driven, patient‑centric approaches and author statistical sections of regulatory documents.

Responsibilities

Lead statistical strategy for vaccine specification setting
Author and review statistical sections of regulatory submissions
Collaborate with cross‑functional teams to align CMC control strategy

Skills

Qualifications

MS in StatisticsPhD in Statistics

About Vaxcyte

vaxcyte.com

Headquarters

San Carlos, California, United States

Company Size

51-200 employees

Founded

2013

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Vaxcyte is a clinical-stage vaccine innovation company dedicated to eliminating bacterial infections — including invasive pneumococcal disease, Group A Strep, and Shigella — using advanced chemistry and a proprietary cell-free protein synthesis platform. Its lead programs, VAX-31 (a 31-valent PCV) and VAX-24 (a 24-valent PCV), are being evaluated in Phase 3 trials for the prevention of invasive pneumococcal disease, with additional early-stage candidates targeting Group A Strep and Shigella. Vaxcyte is also investing up to $1 billion in U.S. biomanufacturing expansion to support scalable vaccine production.