CMC Statistics Director

Role: CMC Statistics Director (Scientific Fellow) providing strategic and technical leadership in statistical sciences across the pharmaceutical product lifecycle, including development, manufacturing, validation, and regulatory submissions. Responsibilities: establish and lead the CMC Statistics Center of Excellence, define standards and best practices, support process characterization, optimization, validation, stability, and lifecycle management; drive adoption of advanced analytics, digital solutions, and AI; author and review statistical content for regulatory interactions; develop statistical training programs; and collaborate closely with Development, Manufacturing, Quality, Regulatory Affairs, Data & Digital teams. Requirements: Ph.D. or M.S. in Statistics, Biostatistics, Engineering, Math, Data Science, or related field; 10+ years (Ph.D.) or 12+ years (M.S.) industry experience supporting CMC activities in pharma or biotech; expertise in DOE, multivariate analysis, process validation, stability, and analytical methods; proficiency with JMP, Minitab, SAS, R, Python; strong knowledge of FDA, EMA, ICH, global regulatory expectations; leadership and stakeholder management skills. High-Value: biologics, cell and gene therapies, small molecules, or combination products; experience influencing regulatory inspections; supporting global regulatory submissions; advancing digital and AI-enabled analytics within regulated environments. Work Setup: hybrid or on-site; flexible work arrangements.