Senior Pharmacometrics Programming Lead

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); In loco; USD 129.000 - 210.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Manager, Pharmacometrics Programming to lead programming and quality control for analyses across multiple projects and to support regulatory submissions.

You will coordinate with cross-functional teams, create and validate specifications, integrate data for PK/PD analyses, and drive process improvements that enhance efficiency and compliance. This role requires on-site work four days per week in Tarrytown, NY.

Competenze

• Bachelor's degree required; Master's degree preferred.
• 7-9+ years of progressive experience in statistical programming in pharma.
• 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.

Mansioni

• 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.

Conoscenze

Project management

Cross-functional collaboration

Communication

Problem-solving

Regulated environment awareness

Pharmacometric analyses

Formazione

Bachelor's degree

Master's degree preferred

Strumenti

SAS

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Manager, Pharmacometrics Programming to lead programming and quality control for analyses across multiple projects and to support regulatory submissions.

You will coordinate with cross-functional teams, create and validate specifications, integrate data for PK/PD analyses, and drive process improvements that enhance efficiency and compliance. This role requires on-site work four days per week in Tarrytown, NY.