Principal Pharmacometrics Programmer

Regeneron Pharmaceuticals • Warren, MI

1d • Onsite

About The Position

A Principal Pharmacometrics Programmer provides timely support to the study team on all programming matters according to the project strategies. Create initial TFLs list for CP report based study SAP and CP TFL standards; Finalized the list with the input from author and writer. Lead programming support for processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan, clinical pharmacology report requirement, Population PK/Population PK/PD analysis requirement and programming specifications using internal standards and guidelines. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment, 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. Lead/participate projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Address statistical ad-hoc requests of senior management, HA, performing exploratory ER analysis upon the requests. This position requires 4 days onsite presence based out of our Tarrytown, NY or Warren, NJ location. In this role, a typical day might include the following: · lead programmer for programming and QC of analysis datasets, TFL's of 1 or more projects following Regeneron standard data models or user requirements. Representation of PMX programming functions and coordination of activities with cross line functions and communicate shifting timelines and milestones. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies. Contribute to standard tools or macros development. · Integration of data across studies in support of Exposure-response, PopPK and PopPKPD analysis and 2.7.2. Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations. · Lead and execute the creation and validation of electronic data submission packages according to CDISC standards (i.e. annotated CRF, data export files, CSDRG, ADRG, 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 report · Participate in department working groups; participate/provide input in development of tools and improvement of processes. Adheres to the SOPs, Guidelines, Working Instructions when processing/analyzing/storing/transferring the data.

Requirements

• Strong SAS programming skills (SAS (Base, Stat, Macro, graph) in a clinical data environment
• Good understanding of relational database structure.
• Understanding of reporting systems utilizing multiple data delivery applications; Strong Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.
• Able to take directives, works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
• Comprehensive understanding of biostatistics, pharmaceutical clinical development (i.e. safety deliverables, efficacy analysis), experienced in data handling, process and analysis and able to undstand/perform Pharmacokinetics, immunogenicity, exposure response analysis in timely manner
• Experience in project management with supervision.
• Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel.
• Skilled in use of relevant software, including Window SAS, SAS EG (Base, Stat, Macro, graph), MS-Excel, R,/R-Studio etc.
• MS. (BS.) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.

Responsibilities

• lead programmer for programming and QC of analysis datasets, TFL's of 1 or more projects following Regeneron standard data models or user requirements.
• Representation of PMX programming functions and coordination of activities with cross line functions and communicate shifting timelines and milestones.
• Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
• Contribute to standard tools or macros development.
• Integration of data across studies in support of Exposure-response, PopPK and PopPKPD analysis and 2.7.2.
• Provide programming support for simple presentations and basic statistical ad-hoc requests.
• Assist in the more complex data presentations.
• Lead and execute the creation and validation of electronic data submission packages according to CDISC standards (i.e. annotated CRF, data export files, CSDRG, ADRG, 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 report
• Participate in department working groups; participate/provide input in development of tools and improvement of processes.
• Adheres to the SOPs, Guidelines, Working Instructions when processing/analyzing/storing/transferring the data.

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: Mid Level
• Number of Employees: 5,001-10,000 employees