CMC Statistics Director

Job Description

GENERAL SUMMARY:

The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the application of statistical sciences across the product lifecycle including process development analytical development manufacturing process validation continued process verification (CPV) stability quality control and regulatory submissions. This individual will establish and lead the CMC Statistics capability enabling data-driven decision-making to enhance product quality process robustness operational efficiency and regulatory compliance. The role partners closely with Development MSAT Quality Regulatory Affairs and Data & Digital teams to ensure the effective application of advanced statistical methodologies across all CMC functions. The position will drive the adoption of best practices in statistical analysis DOE process monitoring and manufacturing data analytics to support Vertexs growing portfolio and evolving manufacturing network.

This individual will demonstrate Vertex Core Values while fostering a culture of scientific excellence continuous improvement innovation collaboration and quality.

Key Duties and Responsibilities:

• Partner with Development Manufacturing Quality Regulatory Affairs and Data & Digital organizations to provide strategic statistical leadership across the CMC lifecycle
• Establish and lead the CMC Statistics Center of Excellence defining standards governance methodologies and best practices for statistical analyses
• Provide statistical leadership for process characterization process optimization process robustness studies technology transfer activities and lifecycle management programs
• Support the application of Design of Experiments (DOE) methodologies to support product and process development optimization and control strategy development
• Develop and implement statistical approaches supporting Process Performance Qualification (PPQ) Continued Process Verification (CPV) Statistical Process Control (SPC) and process capability monitoring
• Support analytical method development qualification validation and lifecycle management through statistically sound study design and data analysis
• Provide advanced statistical support for stability programs shelf-life estimation comparability assessments and global regulatory submissions
• Serve as the subject matter expert for exploratory data analysis outlier assessments regression modeling multivariate analysis and predictive modeling techniques
• Support investigations deviations CAPAs quality risk assessments and manufacturing troubleshooting activities through quantitative data analysis
• Drive adoption of advanced analytics digital solutions machine learning and AI-enabled statistical approaches across Technical Operations and Quality
• Author review and defend statistical content for regulatory submissions and health authority interactions
• Develop and deliver statistical training programs that increase statistical literacy and data-driven decision-making throughout the organization
• Continuously evaluate emerging industry trends technologies and best practices in CMC statistics and pharmaceutical manufacturing analytics

Knowledge and Skills:

• Recognized expertise in statistical methodologies supporting pharmaceutical development manufacturing quality and regulatory submissions
• Extensive knowledge of Design of Experiments (DOE) multivariate analysis regression modeling process capability analysis statistical process control and process validation methodologies
• Strong understanding of Continued Process Verification (CPV) Process Performance Qualification (PPQ) commercial manufacturing monitoring and lifecycle process verification
• Deep understanding of analytical method validation stability analysis shelf-life estimation and comparability assessments
• Proficiency with statistical software platforms including JMP Minitab SAS R Python and other advanced analytics tools
• Strong understanding of FDA EMA ICH and global regulatory expectations related to CMC statistical analyses and process validation
• Knowledge of data integrity principles including ALCOA requirements and their application in regulated environments
• Strong leadership influencing stakeholder management and change management capabilities
• Exceptional written verbal and presentation skills with the ability to communicate effectively across technical and executive audiences

Education and Experience:

• Ph.D. in Statistics Biostatistics Industrial Engineering Applied Mathematics Data Science or related quantitative discipline with 10 years of relevant industry experience; or
• M.S. in Statistics Biostatistics Industrial Engineering Applied Mathematics Data Science or related quantitative discipline with 12 years of relevant industry experience
• Demonstrated experience supporting CMC development process validation manufacturing quality operations and regulatory submissions in a pharmaceutical or biotechnology environment
• Experience applying statistical methodologies across biologics cell and gene therapy small molecules and/or combination products preferred
• Demonstrated success establishing statistical best practices governance models and capability-building programs within regulated environments
• Experience leveraging advanced analytics machine learning digital manufacturing and AI-enabled solutions preferred
• Experience supporting global regulatory inspections responses and health authority interactions is strongly preferred

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at