Associate Director Statistical Programming - Pharmacometrics

About the role

The Associate Director Pharmacometrics Programming provides timely support to the study team on all programming matters according to the project strategies. They lead project leadership, resource planning, and coordinating deliverables within projects or across multiple projects.

Responsibilities

• Lead the programming and QC of analysis datasets, TFL's across multiple projects or standard tools following Regeneron standard data models or user requirements.
• Representation of PMX programming functions and coordination of activities with cross-line functions and support planning/coordinating timelines in data exchange, deliverables.
• Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
• Lead the integration of data across studies in support of Exposure-response, PopPK and PopPKPD analysis.
• Provide programming support for all PMX deliverables in HAR requests, data-driven analysis, publications, conferences.
• Lead the creation and validation of electronic submission requirements (i.e. annotated CRF, data export files, define documents).
• Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports.

Requirements

• Expert SAS programming skills (SAS (Base, Stat, Macro, graph)) in a clinical data environment.
• Strong experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.
• Comprehensive understanding of biostatistics, pharmaceutical clinical development (i.e. safety deliverables, efficacy analysis), experience in data handling, process, and analysis, and ability to perform Pharmacokinetics, immunogenicity, exposure response analysis in a timely manner.
• Mentor junior-level staff in therapeutic area requirements.
• Develop a collaborative work environment and serve as a positive role model.
• Good skills in use of relevant software, including Windows SAS, SAS Studio (Base, Stat, Macro, graph), MS-Excel, R programming, and/or Python.
• Good knowledge of AI use cases in statistical programming and data sciences.

Qualifications

• A Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline.
• 10+ years of programming experience, preferably in processing clinical trial data in the biotechnology, pharmaceutical, or health-related industry.
• Experience in project and people management, and expertise in one or more therapeutic areas is preferred.
• SAS Certification desirable in statistics, computer science.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on the country of employment, 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.