Associate Director, CMC Statistician

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/pharma, excellent technical writing and communication skills, and a practical, data-driven approach to cross-functional decision making.

Essential Functions:

• 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.
• Design and execute statistical analyses such as confidence intervals, prediction intervals, tolerance intervals, regression, ANOVA, DOE, equivalence testing, trend analysis, control charts, and Cpk/process capability analyses.
• Provide statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management.
• Author and review statistical sections of specification and JOS documents, CMC technical reports, regulatory submission sections, and briefing materials.
• Assess analytical method performance and method lifecycle changes, including precision, transfer/bridging, comparability, and impact of analytical variability on specification decisions.
• Partner with Process Development, MSAT, Stability, QA, RA, Manufacturing, and external partners to align statistical rationale with CMC control strategy and regulatory expectations.
• Support PPQ, APR, and CPV activities by evaluating process consistency, state of control, trends, internal control limits, and capability relative to proposed or registered specifications.
• Translate complex statistical concepts into clear recommendations for cross-functional teams, senior leaders, and non-statistical stakeholders; support audits, inspections, and health authority interactions as needed.

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. Other combinations of education and/or experience may be considered.

• Significant hands-on experience in CMC statistics, including specification setting, JOS preparation, analytical method evaluation, stability analysis, process validation, PPQ, CPV, and/or commercial manufacturing support.
• Demonstrated experience supporting BLA, MAA, IND, or major health authority submissions and responses; BLA experience strongly preferred.
• Strong understanding of late-stage and commercial specification-setting principles, including clinical relevance, patient-centric justification, manufacturing experience, analytical capability, stability data, and lifecycle considerations.
• Experience with vaccines, biologics, complex modalities, multivalent products, conjugates, or adjuvanted products is strongly preferred.
• Strong expertise in statistical methods used in CMC and analytical development, including regression, ANOVA, DOE, equivalence testing, tolerance/prediction intervals, control charts, process capability, and stability/shelf-life modeling.
• Proficiency with statistical software such as R, SAS, JMP, Python, Minitab, or equivalent tools.
• Comprehensive understanding of relevant regulatory expectations and guidance, including FDA, EU, WHO, and ICH principles applicable to biologics/vaccines, specifications, analytical methods, validation, stability, and lifecycle management.
• Significant experience authoring technical and regulatory-ready documents, including statistical reports, JOS sections, protocols, validation reports, SOPs, and CMC submission content.
• Excellent communication and interpersonal skills, both written and verbal; able to explain complex statistical concepts clearly and influence cross-functional decisions in a fast-paced environment.
• Strong strategic and analytical decision-making skills; able to navigate ambiguity, prioritize across competing demands, and implement practical, phase-appropriate, and compliant approaches.
• Self-starter with proven project management capability and the ability to work independently in a remote, matrixed, and highly collaborative environment.