Associate Director, CMC Statistician

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the statistical leader for the CMC in the VSWG, aiding in the strategy for setting specifications related to drug substance, drug product, intermediates, raw materials, release testing, stability testing, and in-process testing.

• Formulate statistical strategies for specification and JOS by leveraging clinical insights, manufacturing knowledge, stability behavior, analytical variability, assay capability, and process capability.

• Plan and carry out statistical analyses including confidence intervals, prediction intervals, tolerance intervals, regression, ANOVA, DOE, equivalence testing, trend analysis, control charts, and Cpk/process capability assessments.

• Offer statistical contributions to late-stage development, PPQ, BLA/MAA submissions, responses to health authorities, commercial preparedness, and management of specification lifecycles.

• Write and review statistical components of specification and JOS documents, CMC technical reports, regulatory submission sections, and briefing materials.

• Evaluate analytical method performance and changes throughout the method lifecycle, encompassing precision, transfer/bridging, comparability, and the influence of analytical variability on specification decisions.

• Collaborate with Process Development, MSAT, Stability, QA, RA, Manufacturing, and external partners to ensure statistical justification aligns with CMC control strategies and regulatory standards.

• Assist in PPQ, APR, and CPV initiatives by analyzing process consistency, state of control, trends, internal control limits, and capability in relation to proposed or registered specifications.

• Simplify intricate statistical concepts into actionable recommendations for cross-functional teams, senior leadership, and non-statistical stakeholders; provide support during audits, inspections, and interactions with health authorities as needed.

⛳️ Requirements

• MS or PhD in Statistics, Biostatistics, Applied Statistics, Mathematics, Data Science, or a related quantitative field, along with over 10 years of experience in the pharmaceutical or biotechnology sector.

• Substantial practical experience in CMC statistics, encompassing specification setting, JOS preparation, analytical method assessment, stability analysis, process validation, PPQ, CPV, and/or support for commercial manufacturing.

• Proven experience in supporting BLA, MAA, IND, or major submissions and responses to health authorities; preference for candidates with BLA experience.

• Deep understanding of principles related to late-stage and commercial specification setting, focusing on clinical relevance, patient-centric justification, manufacturing experience, analytical capabilities, stability data, and lifecycle considerations.

• Experience with vaccines, biologics, complex modalities, multivalent products, conjugates, or adjuvanted products is highly desirable.

• Extensive knowledge of statistical methods applied in CMC and analytical development, such as regression, ANOVA, DOE, equivalence testing, tolerance/prediction intervals, control charts, process capability, and stability/shelf-life modeling.

• Proficient in statistical software tools such as R, SAS, JMP, Python, Minitab, or similar applications.

• Thorough understanding of relevant regulatory expectations and guidelines, including those from FDA, EU, WHO, and ICH, as they pertain to biologics/vaccines, specifications, analytical methods, validation, stability, and lifecycle management.

• Significant experience in creating technical and regulatory-ready documents, including statistical reports, JOS sections, protocols, validation reports, SOPs, and content for CMC submissions.

• Outstanding written and verbal communication skills; adept at clarifying complex statistical ideas and influencing cross-functional decisions in a dynamic environment.

• Strong strategic and analytical decision-making abilities; capable of managing ambiguity, prioritizing competing demands, and executing practical, phase-appropriate, and compliant strategies.

• Self-motivated individual with demonstrated project management skills and the ability to work independently in a remote, matrixed, and highly collaborative setting.

🏝️ Benefits

• Comprehensive benefits package

• Equity component