Associate Director Statistical Programming - Pharmacometrics

About the role

The Associate Director Pharmacometrics Programming supports the study team on all programming matters according to project strategies. They lead programming support for processing/analyzing/storing data from clinical studies, providing guidance on implementing and executing programming standards. This role involves designing and testing program logic, coding programs, and preparing program documentation.

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.
• Represent PMX programming functions and coordinate activities with cross-line functions and support planning/coordinating timelines in data exchange, deliverables.
• Create, manage, and maintain programming specifications for 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 deliverables in HAR requests, data-driven analysis, publications, conferences.
• 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), 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
• Good skilled in use of relevant software, including Windows SAS, SAS Studio (Base, Stat, Macro, graph), MS-Excel, R programming, and/or Python
• Good knowledge in 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

Skills

• 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), experience in data handling, process, and analysis, and ability to perform Pharmacokinetics, immunogenicity, exposure response analysis in a timely manner
• Good skilled in use of relevant software, including Windows SAS, SAS Studio (Base, Stat, Macro, graph), MS-Excel, R programming, and/or Python
• Good knowledge in AI use cases in statistical programming and data sciences