Director, Statistical Programming, Pharmacometrics
Regeneron Pharmaceuticals
Summary
At Regeneron, our mission is to use science and innovation to deliver life-changing medicines for patients worldwide. As a Director, Pharmacometrics Programming, you will lead strategic programming initiatives supporting clinical development programs across therapeutic areas. This position combines technical leadership, organizational influence, and people management to ensure high-quality pharmacometric analyses and regulatory deliverables. You will help shape departmental strategy, drive standardization and innovation, develop programming talent, and collaborate with stakeholders across the organization to advance critical development programs from clinical studies through regulatory submissions and beyond.
Job description
Discover your role
- Lead programming strategy and execution across multiple therapeutic areas and clinical development programs.
- Drive implementation of standardized tools, technologies, and methodologies that support analysis and reporting.
- Coordinate pharmacometrics programming activities, timelines, and deliverables with cross-functional partners.
- Guide the integration of data across studies to support exposure-response, population PK, and population PK/PD analyses.
- Lead planning and validation of electronic submission deliverables and supporting documentation.
- Develop talent through hiring, coaching, performance management, and career development activities.
- Champion process improvements, operational excellence, and adoption of departmental standards.
- Represent the pharmacometrics programming function in strategic, operational, and organizational discussions.
This role requires
- Master's degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.
- 12+ years of programming experience supporting clinical trial data within the biotechnology, pharmaceutical, healthcare, or related industry.
- SAS Certification desirable.
- Expert SAS programming experience in a clinical development environment.
- Experience leading teams of 4 or more direct reports.
- Demonstrated success leading complex clinical development projects and managing people and resources.
- Strong understanding of pharmacometrics, biostatistics, clinical trial reporting, and regulatory submission requirements.
- Experience implementing CDISC standards and programming standardization methodologies.
- Strong leadership, strategic thinking, communication, and stakeholder management skills.
Requirements
- Master's degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.
- 12+ years of programming experience supporting clinical trial data within the biotechnology, pharmaceutical, healthcare, or related industry.
- SAS Certification desirable.
- Expert SAS programming experience in a clinical development environment.
- Experience leading teams of 4 or more direct reports.
- Demonstrated success leading complex clinical development projects and managing people and resources.
- Strong understanding of pharmacometrics, biostatistics, clinical trial reporting, and regulatory submission requirements.
- Experience implementing CDISC standards and programming standardization methodologies.
- Strong leadership, strategic thinking, communication, and stakeholder management skills.
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.