CMC Statistics Director

GENERAL

SUMMARY:

The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for applying statistical sciences across the product lifecycle, including process development, analytical development, manufacturing, process validation, continued process verification (CPV), stability, quality control, and regulatory submissions. Establishes and leads the CMC Statistics capability and partners with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive adoption of statistical best practices (including DOE), process monitoring, and manufacturing data analytics.

• Provide strategic statistical leadership across the CMC lifecycle.
• Establish and lead a CMC Statistics Center of Excellence (standards, governance, methodologies, best practices).
• Lead statistical work for characterization, optimization, robustness studies, technology transfer, and lifecycle management.
• Apply DOE for development, optimization, and control strategy development.
• Implement statistical approaches for PPQ, CPV, SPC, and process capability monitoring.
• Support analytical method development/validation/lifecycle management with sound study design and analysis.
• Support stability programs, shelf-life estimation, comparability, and global regulatory submissions.
• Serve as SME for exploratory data analysis, outlier assessment, regression, multivariate, and predictive modeling.
• Support investigations, deviations, CAPAs, quality risk assessments, and troubleshooting via quantitative analysis.
• Drive adoption of advanced analytics, digital solutions, and ML/AI-enabled statistical approaches.
• Author/review/defend statistical content for regulatory submissions and health authority interactions.
• Develop and deliver statistical training programs.
• Monitor emerging trends/technologies in CMC statistics and pharmaceutical manufacturing analytics.

• Expertise in statistical methodologies for pharma development/manufacturing/quality/regulatory.
• Strong knowledge of DOE, multivariate analysis, regression, process capability, SPC, and process validation.
• Understanding of CPV, PPQ, commercial manufacturing monitoring, and lifecycle verification.
• Knowledge of analytical method validation, stability analysis, shelf-life estimation, and comparability.
• Proficient with JMP, Minitab, SAS, R, Python, and other advanced analytics tools.
• Understanding of FDA/EMA/ICH/global CMC statistical expectations.
• Knowledge of data integrity principles (ALCOA+).
• Leadership and change management skills; strong communication across technical and executive audiences.

• Ph.D. (10+ years) or M.S. (12+ years) in Statistics/Biostatistics/Industrial Engineering/Applied Mathematics/Data Science or related quantitative discipline.
• Demonstrated CMC development/process validation/manufacturing/quality/regulatory submission experience in pharma/biotech.
• Preferred: biologics/cell & gene therapy/small molecules/combination products experience.
• Preferred: establishing statistical best practices/governance/capability-building in regulated environments.
• Preferred: advanced analytics, machine learning, digital manufacturing, AI-enabled solutions.
• Strongly preferred: support for global regulatory inspections, responses, and health authority interactions.