Associate Director, CMC Statistician

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🏄 California – Remote

🏄 California – Remote

💵 $170k - $198k / year

⏰ Full Time

🟠 Senior

👔 Director

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• 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. • 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.

🏖️ Benefits

• Comprehensive benefits package • Equity component