Responsibilities
- Act as the CMC statistical lead for the VSWG, guiding specification-setting strategy for drug substance, drug product, intermediates, raw materials, release testing, stability testing, and in-process testing.
- Create statistical strategies for specifications and justification of specifications using clinical and manufacturing experience, stability behavior, analytical variability, assay capability, and process capability.
- Design and perform statistical analyses including confidence intervals, prediction intervals, tolerance intervals, regression, ANOVA, design of experiments, equivalence testing, trend analysis, control charts, and Cpk/process capability analyses.
- Offer statistical guidance for late-stage development, process performance qualification, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management.
- Write and review statistical sections of specification and justification of specification documents, CMC technical reports, regulatory submission sections, and briefing materials.
- Evaluate analytical method performance and method lifecycle changes, covering precision, transfer/bridging, comparability, and the effect of analytical variability on specification decisions.
- Collaborate with Process Development, MSAT, Stability, QA, RA, Manufacturing, and external partners to align statistical reasoning with CMC control strategy and regulatory expectations.
- Support PPQ, annual product review, and continued process verification activities by assessing 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.
Nice to Have
- Experience with vaccines, biologics, complex modalities, multivalent products, conjugates, or adjuvanted products is strongly preferred.
Benefits
- Comprehensive benefits
- Equity component
