Associate Director, CMC Statistician

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.

Reports to: Senior Director, Global Analytical Lead - Commercial Readiness and Analytical Strategy

Location: San Carlos, CA

Work Arrangement: Remote

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $170,000 - $198,000

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.