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.
• 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.