CMC Statistics Director

Vertex Pharmaceuticals seeks a CMC Statistics Director to lead statistical strategy across the product lifecycle, from process development through regulatory submissions. This Scientific Fellow will establish statistical best practices, drive data-driven decision-making, and partner across development, manufacturing, quality, and regulatory teams to enhance product quality and operational efficiency.

Responsibilities

• Lead CMC Statistics Center of Excellence, establishing standards, governance, and best practices for statistical analyses
• Provide strategic statistical guidance for process characterization, optimization, robustness studies, and technology transfer activities
• Support Design of Experiments, Process Performance Qualification, Continued Process Verification, and statistical process control implementations
• Develop statistical approaches for analytical method validation, stability programs, shelf-life estimation, and comparability assessments
• Drive adoption of advanced analytics, machine learning, and AI-enabled solutions across technical operations and quality functions

Requirements

• Ph.D. in Statistics, Biostatistics, Industrial Engineering, Applied Mathematics, or related quantitative discipline with 10+ years industry experience; or M.S. with 12+ years
• Expertise in Design of Experiments, multivariate analysis, process validation, and statistical process control methodologies
• Demonstrated experience supporting CMC development, process validation, manufacturing, and regulatory submissions in pharma or biotech
• Proficiency with statistical software including JMP, Minitab, SAS, R, and Python
• Strong understanding of FDA, EMA, ICH regulatory expectations for CMC statistical analyses
• Leadership, stakeholder management, and change management capabilities
• Exceptional written and verbal communication skills across technical and executive audiences