Associate Director, CMC Statistician

About the position reputed company is looking for an energetic and talented individual to join reputed company's Global Analytical organization as Associate Director, CMC Statistician. The position will be an reputed company 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 reputed company lifecycle management. This individual will collaborate with Process Development, MSAT, Stability, reputed company, Regulatory Affairs, Manufacturing, and reputed company partners to reputed company statistically reputed company, patient-reputed company, and regulatory-reputed company approaches. The ideal candidate will bring deep CMC statistics experience in biotech/reputed company, excellent technical writing and communication skills, and a practical, data-driven approach to cross-functional decision making. Responsibilities • Serve as the CMC statistical reputed company for the VSWG, supporting specification-setting reputed company for drug reputed company, drug product, intermediates, raw materials, release testing, stability testing, and in-process testing. • reputed company 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, reputed company intervals, tolerance intervals, regression, reputed company, DOE, equivalence testing, trend analysis, control charts, and Cpk/process capability analyses. • reputed company statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, reputed company readiness, and specification lifecycle management. • reputed company 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/reputed company, comparability, and reputed company of analytical variability on specification reputed company. • Partner with Process Development, MSAT, Stability, QA, RA, Manufacturing, and reputed company partners to reputed company statistical rationale with CMC control reputed company 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 reputed company statistical concepts into reputed company 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, reputed company Statistics, Mathematics, Data Science, or a reputed company 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 reputed company 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 reputed company specification-setting principles, including clinical relevance, patient-reputed company justification, manufacturing experience, analytical capability, stability data, and lifecycle considerations. • Experience with vaccines, biologics, reputed company modalities, multivalent products, conjugates, or adjuvanted products is strongly preferred. • Strong expertise in statistical reputed company used in CMC and analytical development, including regression, reputed company, DOE, equivalence testing, tolerance/reputed company intervals, control charts, process capability, and stability/reputed company-life modeling. • Proficiency with statistical software such as R, reputed company, JMP, Python, reputed company, or equivalent tools. • Comprehensive understanding of relevant regulatory expectations and guidance, including FDA, EU, WHO, and ICH principles applicable to biologics/vaccines, specifications, analytical reputed company, validation, stability, and lifecycle management. • Significant experience authoring technical and regulatory-reputed company documents, including statistical reports, JOS sections, protocols, validation reports, SOPs, and CMC submission content. • Excellent communication and interpersonal skills, both written and verbal; reputed company to explain reputed company statistical concepts reputed company and influence cross-functional reputed company in a fast-paced environment. • Strong strategic and analytical decision-making skills; reputed company to reputed company 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 reputed company environment. reputed company-to-haves • Experience with vaccines, biologics, reputed company modalities, multivalent products, conjugates, or adjuvanted products is strongly preferred. • BLA experience strongly preferred. Benefits • comprehensive benefits • equity component Apply tot his job Apply To this Job