CMC Statistics Director

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 193,000 - 290,000; Full time

Job summary

Vertex Pharmaceuticals Inc seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle, including development, manufacturing, validation, and regulatory submissions. You will establish a Statistics Center of Excellence, drive DOE practices, and promote data-driven decision making across Development, MSAT, Quality, and Regulatory Affairs.

Ideal candidates hold a PhD or MS in a quantitative field with 10–12+ years in pharma/biotech and experience

Qualifications

• Ph.D. in Statistics or related field with 10+ years of industry experience.
• MS in Statistics or related field with 12+ years of experience in industry.
• Experience supporting CMC development and regulatory submissions.
• Experience across biologics, cell/gene therapy, or small molecules.
• Proven success building statistical governance and best practices.
• Experience with AI/ML and digital manufacturing preferred.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Establish and lead the CMC Statistics Center of Excellence.
• Support DOE, PPQ, CPV, SPC, and process validation activities.
• Defend statistical content for regulatory submissions.
• Develop statistical training to improve data-driven decision making.
• Stay updated on industry trends in CMC statistics.

Skills

Statistical leadership

DOE

Multivariate analysis

Regression modeling

SPC

PPQ/CPV

Data analytics

Regulatory writing

Leadership

Communication

Education

PhD in Statistics or related

MS in Statistics or related

Tools

JMP

Minitab

SAS

R

Python

Job description

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.

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life‑shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion‑dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1‑mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha‑1 antitrypsin deficiency. Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 14 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X, LinkedIn, YouTube and Instagram.

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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 [e-mail].