Associate Director Statistical Programming - Pharmacometrics

Regeneron Pharmaceuticals • Tarrytown, GA

4d • Hybrid

About The Position

Associate Director Pharmacometrics Programming provides timely support to the study team on all programming matters according to the project strategies. Provides project leadership, resource planning/coordinating deliverables within project or across multiple projects. Lead programming support for processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan, clinical pharmacology report requirement and programming specifications using internal standards and guidelines. Providing guidance in implementing and executing the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. The incumbent is responsible for addressing administrative functions required for project management such as compilation of resource requirements and milestones, identifying/communicating changes in project requirements that may affect key deliverables at the project level, and working with the department head to develop resource strategies. This position requires 4 days onsite presence based out of our Tarrytown, NY or Warren, NJ location. A typical day might include the following: 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 and 2.7.2. Provide programming support for all PMX deliverable in HAR request, data driven analysis, publications, conference Plan and 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
• Understanding of relational database structure and reporting systems utilizing multiple data delivery applications
• 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), experienced in data handling, process and analysis and able to understand/perform Pharmacokinetics, immunogenicity, exposure response analysis in timely manner
• Master in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.
• 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.

Nice To Haves

• Experience in project and people management, and expertise in one or more therapeutic areas is also preferred.
• SAS Certification desirable in statistics, computer science.
• Good knowledges in AI use case in statistical programming and data sciences.

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 and 2.7.2.
• Provide programming support for all PMX deliverable in HAR request, data driven analysis, publications, conference Plan and 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

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior