[Hiring] Associate Director, CMC Statistician @reputed company

Role Description 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 integral 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, Quality, Regulatory Affairs, Manufacturing, and external partners to reputed company statistically sound, patient-centric, and regulatory-reputed company approaches. The ideal candidate will bring deep CMC statistics experience in biotech/pharma, excellent technical writing and communication skills, and a practical, data-driven approach to cross-functional decision making. Essential Functions

• Serve as the CMC statistical reputed company for the VSWG, supporting specification-setting strategy for drug substance, 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, ANOVA, 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.
• 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 reputed company.
• 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 reputed company statistical concepts into clear recommendations for cross-functional teams, senior leaders, and non-statistical stakeholders; support audits, inspections, and health authority interactions as needed.

Qualifications

• MS or PhD in Statistics, Biostatistics, Applied 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-centric 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 methods used in CMC and analytical development, including regression, ANOVA, 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 methods, 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 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.

Requirements

• Reports to: Senior Director, Global Analytical reputed company - reputed company 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 reputed company: $170,000 - $198,000

Equal Opportunity Employer We are an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or veteran status. Apply To This Job