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 Vertex's 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:

$193,100 - $289,700

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

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 Vertex’s 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 person's 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 ApplicationAssistance@vrtx.com