Manager, Statistical Programming, Pharmacometrics
About The Position
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.
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.
Responsibilities
- 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.
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
