Vaxcyte

Biotechnology

AssociateDirector,CMCStatistician

$170–198k San Carlos, California, United States Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Associate Director, CMC Statistician at Vaxcyte. Skills: CMC statistics, Specification setting, Statistical analysis, Regulatory guidance. Serve as CMC statistical lead for VSWG. Support specification-setting strategy”

Industry & Context.

Biotechnology
Problems you'll solve

Analytical decision-making; Data-driven decision making

What They're Looking For.

Must Have

MS or PhD in Statistics, Biostatistics, Applied Statistics, Mathematics, Data Science, or related quantitative discipline, 10+ years of experience in pharmaceutical or biotechnology industry, Significant hands-on experience in CMC statistics, Demonstrated experience supporting BLA, MAA, IND, or major health authority submissions, Understanding of late-stage and commercial specification-setting principles, Expertise in statistical methods used in CMC and analytical development, Proficiency with statistical software such as R, SAS, JMP, Python, Minitab, or equivalent tools, Comprehensive understanding of relevant regulatory expectations and guidance, Significant experience authoring technical and regulatory-ready documents, Excellent communication and interpersonal skills, Strategic and analytical decision-making, Project management capability, Ability to work independently

Nice to Have

BLA experience strongly preferred, Experience with vaccines, biologics, complex modalities, multivalent products, conjugates, or adjuvanted products is strongly preferred

What You'll Do.

Serve as CMC statistical lead for VSWG

Support specification-setting strategy

Develop statistical strategies for specification and JOS

Design and execute statistical analyses

Provide statistical input to development

Author and review statistical sections of documents

Assess analytical method performance

Partner with Process Development

Translate complex statistical concepts into clear recommendations

Support health authority interactions

How You'll Work.

Team & Collaboration

Cross-functional teams; Senior leaders; Non-statistical support; External partners; Matrixed environment

Communication Scope

Written communication; Verbal communication; Explain complex concepts

Process & Methodology

Project management

Full Job Description

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Global Analytical organization as Associate Director, CMC Statistician. The position will be an integral part of the Vaccine Specification Working Group (VSWG), providing statistical leadership for specification setting and Justification of Specifications (JOS) across late-stage development, PPQ, BLA readiness, and commercial lifecycle management. This individual will collaborate with Process Development, MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and external partners to develop statistically sound, patient-centric, and regulatory-ready approaches. The ideal candidate will bring deep CMC statistics experience in biotech/p

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