Overview In this role you will lead programming activities to support clinical study analysis and reporting in alignment with study strategies and regulatory requirements. You will guide PMX standards, data integration across studies, and cross-functional collaboration to ensure timely, high-quality deliverables. You'll design and validate program logic, manage resources and milestones, and mentor junior staff in pharmacometric programming. The opportunity combines technical leadership with strategic oversight to enable regulatory submission and product development. You will work onsite four days a week in Tarrytown, NY or Warren, NJ and contribute to Regeneron's mission in biotech/pharma.
Compensation / Benefits- inclusive culture
- comprehensive benefits (health, dental, vision, life, disability)
- fitness centers
- 401(k) company match
- family support benefits
- annual bonuses
Responsibilities- Lead programming and QC of analysis datasets and TFLs across projects using Regeneron data models and standards
- Coordinate PMX activities with cross-functional teams and manage data exchange timelines
- Create and maintain programming specifications for analysis datasets
- Lead data integrations for exposure-response, PopPK and PopPKPD analyses
- Provide programming support for PMX deliverables, publications, and HAR requests
- Plan and oversee creation/validation of electronic submission requirements
- Collaborate in multidisciplinary study teams to support analyses up to regulatory approval
Key requirements- Expert SAS programming skills (Base, Stat, Macro, Graph) in a clinical data environment
- Strong knowledge of relational database structures and reporting across data delivery apps
- Experience implementing standardization methodologies and CDISC data standards
- Understanding of biostatistics and pharmacokinetics/pharmacology analyses
- Mentor experience and ability to foster collaborative team environments
- Proficiency with Windows SAS, SAS Studio, MS-Excel, R or Python
- Knowledge of AI use cases in statistical programming and data science
- 10+ years of programming experience in biotechnology/pharmaceutical health-related industry
- Master in Statistics/CS/Math/Engineering/Life Science or related discipline
- mentoring and leadership
- cross-functional communication
- problem-solving
- SAS (Base, Stat, Macro, Graph)
- SAS Studio
- R programming
