Statistician, CMC (Chemistry, Manufacturing, and Controls)

About the role

Responsibilities

• Design and execute comparability assessments for process changes, site transfers, scale- up/scale-down activities, and reference standard qualification, utilizing equivalence testing, quality range methods, and mixed-effects models to establish pre-specified acceptance criteria.
• Develop and apply tolerance interval methodologies (parametric, non-parametric, and distribution-free approaches) to establish specifications, in-process control limits, and shelf- life/stability ranges across the product lifecycle.
• Conduct Bland-Altman analysis and method-agreement/method-transfer evaluations to assess bias, limits of agreement, and comparability between analytical platforms, instruments, and laboratories.
• Provide statistical support for analytical method validation and verification, including accuracy, precision, linearity, range, and robustness studies, with particular expertise in handling non- normal and skewed data through transformation strategies and non-parametric methods.
• Author and review statistical sections of validation protocols, reports, and summary statistics packages suitable for regulatory submissions (BLA/MAA/NDA, CTD Module 3) and responses to health authority queries.
• Develop, validate, and maintain statistical code and templates (R, SAS, JMP, Python) to ensure consistency, traceability, and reproducibility of analyses; stay current with ICH, FDA, and EMA guidance on comparability, analytical procedures, and statistical methods.
• Collaborate with Analytical Development, Process Development, QC, and Regulatory Affairs to design fit-for-purpose experimental designs (DOE), sampling plans, and risk assessments while communicating statistical concepts clearly to non-specialist stakeholders.