Vaxcyte
Biotechnology
AssociateDirector,CMCStatistician
Neural analysis suggests this role is
optimal for Director candidates.
“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.
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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