Manager, Statistical Programming, Pharmacometrics
Regeneron Pharmaceuticals
Summary
At Regeneron, we use data, science, and innovation to accelerate the development of transformative medicines. As a Manager, Pharmacometrics Programming, you will provide programming leadership supporting clinical development programs and pharmacometric analyses that inform critical development decisions. This role offers the opportunity to work across multidisciplinary teams, contribute to regulatory submissions, and drive the delivery of high-quality analyses that support clinical pharmacology and development objectives. You will also help advance departmental standards, improve processes, and strengthen programming capabilities that enable efficient and compliant drug development.
Job description
Discover your role
- Lead programming and quality control activities for analysis datasets, tables, figures, and listings across multiple projects.
- Coordinate pharmacometrics programming activities and deliverables with cross-functional teams and study stakeholders.
- Create, maintain, and validate programming specifications that support standardized analyses and reporting.
- Integrate data across studies to support exposure-response, population PK, and population PK/PD analyses.
- Support regulatory requests, data-driven analyses, scientific publications, and conference presentations.
- Lead creation and validation of electronic submission deliverables and supporting documentation.
- Partner with multidisciplinary study teams to deliver high-quality clinical trial analyses and reports.
- Drive process improvements, standards development, and departmental initiatives that enhance efficiency and compliance.
This role requires
- Bachelor's degree required; Master's degree preferred
- Must have 7-9+ years of progressive experience in statistical programming. Experience in pharma regulated environment preferred.
- Advanced SAS programming experience within a clinical research or pharmaceutical environment.
- Strong understanding of pharmacometrics analyses, including pharmacokinetics, immunogenicity, exposure-response, and population PK methodologies.
- Experience supporting clinical study reporting, regulatory deliverables, and CDISC data standards.
- Strong project management, communication, problem-solving, and cross-functional collaboration skills.
- Ability to manage multiple priorities while delivering high-quality work in a regulated environment.
Requirements
- Bachelor's degree required; Master's degree preferred
- Must have 7-9+ years of progressive experience in statistical programming
- Experience in pharma regulated environment preferred
- Advanced SAS programming experience within a clinical research or pharmaceutical environment
- Strong understanding of pharmacometrics analyses, including pharmacokinetics, immunogenicity, exposure-response, and population PK methodologies
- Experience supporting clinical study reporting, regulatory deliverables, and CDISC data standards
- Strong project management, communication, problem-solving, and cross-functional collaboration skills
- Ability to manage multiple priorities while delivering high-quality work in a regulated environment
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.