CMC Statistics Director

Vertex Pharmaceuticals · Boston, MA

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BiometricsFull-time$193k–$290kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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