Vaxcyte
Associate Director, CMC Statistician
San Carlos, California, United States · Director
Sponsorship not specified$170k-$198kDetected 48 days ago
PythonData ScienceStatisticsProject ManagementFDA RegulatorySASLeadershipCommunicationCollaborationWritingBiostatisticsRegulatory Affairs
About the role
- 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.
Responsibilities
- Senior Director, Global Analytical Lead - Commercial Readiness and Analytical Strategy
- Serve as the CMC statistical lead for the VSWG, supporting specification-setting strategy for drug substance, drug product, intermediates, raw materials, release testing, stability testing, and in-process testing.
- Develop statistical strategies for specification and JOS using clinical experience, manufacturing experience, stability behavior, analytical variability, assay capability, and process capability.
- Author and review statistical sections of specification and JOS documents, CMC technical reports, regulatory submission sections, and briefing materials.
- Partner with Process Development, MSAT, Stability, QA, RA, Manufacturing, and external partners to align statistical rationale with CMC control strategy and regulatory expectations.
Requirements
- MS or PhD in Statistics, Biostatistics, Applied Statistics, Mathematics, Data Science, or a related quantitative discipline with 10+ years of experience in the pharmaceutical or biotechnology industry.
- Proficiency with statistical software such as R, SAS, JMP, Python, Minitab, or equivalent tools.
Nice to have
- BLA experience strongly preferred.
- Experience with vaccines, biologics, complex modalities, multivalent products, conjugates, or adjuvanted products is strongly preferred.
Compensation
- $170,000 - $198,000
- The compensation package will be competitive and includes comprehensive benefits and an equity component.
Benefits
- Provide statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management.
Company info
- Join our Mission to Protect Humankind!
Equal opportunity
- We are an equal opportunity employer.
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This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.