The role will be accountable for statistical support of specification setting, stability trending and shelf-life assessment, analytical method bridging and transfer, comparability assessments, method validation, process and product monitoring, investigations, and lifecycle management. This individual will partner with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to develop scientifically sound, phase-appropriate, and regulatory-defensible statistical strategies for drug substance and drug product development.