Senior Statistical Programmer - Pharmacometrics

$92,500 - $151,100/Yr

Regeneron Pharmaceuticals - Tarrytown, NY

Full-time - Mid Level

Hybrid - Tarrytown, NY

Professional, Scientific, and Technical Services

About the position

The Senior Pharmacometric Programmer plays a crucial role in supporting the study team by managing programming tasks related to clinical studies. This hybrid position requires the programmer to work onsite three days a week in Tarrytown, NY, and involves processing, analyzing, and storing clinical data according to established guidelines and statistical analysis plans. The role emphasizes collaboration with multidisciplinary teams to ensure timely and quality support for clinical trial analysis and reporting, ultimately contributing to regulatory approval and product launch.

Responsibilities

• Lead and support programming and quality control of analysis datasets and TFLs for multiple studies.
• Represent PMX programming functions and coordinate activities with cross-functional teams, communicating shifting timelines and milestones.
• Create, manage, and maintain programming specifications for analysis datasets using Regeneron tools and methodologies.
• Integrate data across studies to support Exposure-response, PopPK, and PopPKPD analyses.
• Create and validate electronic submission packages, including annotated CRFs and data export files.
• Work collaboratively within a multidisciplinary study team to provide timely and quality support for clinical trial analysis and reporting.

Requirements

• MS or BS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related field.
• 3+ years of programming experience, preferably in processing clinical trial data in the biotechnology, pharmaceutical, or health-related industry.
• Good SAS programming skills (Base, Stat, Macro, graph) in a clinical data environment.
• Understanding of relational database structures and reporting systems utilizing multiple data delivery applications.
• Experience with implementing standardization methodology and creation of current CDISC data standards.
• Good understanding of biostatistics and pharmaceutical clinical development, including safety deliverables and efficacy analysis.

Nice-to-haves

• Experience in data handling, process, and analysis related to pharmacokinetics and immunogenicity.
• Skilled in using relevant software, including Windows SAS, SAS EG, MS-Excel, and R/R-Studio.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off