Manager Statistical Programming
Regeneron
4 months ago
On-site
Warren, NJ
Clinical Research and Development
Manager Statistical Programming responsibilities include:
- Provide timely support to the study team on programming matters per project strategies.
- Provide project leadership and programming support for processing data from clinical studies.
- Lead the programming aspect of a project (internally and/or with CROs) for all programming deliverables from study start through regulatory approval, product launch, data monitoring boards, and annual reports.
- Guide implementation and execution of programming and project standards; support requirements defined by the Statistical Analysis Plan, programming specification, or user requirements.
- Oversee documentation and ensure consistent maintenance of code, logs, and output in a regulated environment.
- Function as lead programmer; develop and QC tables, listings, graphs, or systems to support analysis requirements using CDISC SDTM/ADaM and current industry standards.
- Manage programming effort and submission deliverables using tools to track, allocate, and summarize scope, progress, and completion; support complex presentations and statistical ad hoc requests.
- Act as programming representative on a multidisciplinary study team to ensure timely, quality analysis and reporting for clinical trials up to regulatory approval and ongoing reporting.
- If applicable, lead application development and represent programming to the user audience.
- Work with management to determine resource requirements for therapeutic area/department responsibilities.
- Review and select candidates; screen and interview for contractor and permanent roles; provide feedback on contributions, evaluate performance, and recommend yearly goals.
- Advise direct reports on retention procedures for data, records, and employee information.
Qualifications/requirements:
- Master’s Degree.
- 8–10 years of relevant work experience.
- SAS Certification desirable.
- Alternatively: 5+ years of programming experience processing clinical trial data in biotechnology/pharmaceutical/health industry, including some project and people management experience with a Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
Application instructions:
- Apply now.
- Provide timely support to the study team on programming matters per project strategies.
- Provide project leadership and programming support for processing data from clinical studies.
- Lead the programming aspect of a project (internally and/or with CROs) for all programming deliverables from study start through regulatory approval, product launch, data monitoring boards, and annual reports.
- Guide implementation and execution of programming and project standards; support requirements defined by the Statistical Analysis Plan, programming specification, or user requirements.
- Oversee documentation and ensure consistent maintenance of code, logs, and output in a regulated environment.
- Function as lead programmer; develop and QC tables, listings, graphs, or systems to support analysis requirements using CDISC SDTM/ADaM and current industry standards.
- Manage programming effort and submission deliverables using tools to track, allocate, and summarize scope, progress, and completion; support complex presentations and statistical ad hoc requests.
- Act as programming representative on a multidisciplinary study team to ensure timely, quality analysis and reporting for clinical trials up to regulatory approval and ongoing reporting.
- If applicable, lead application development and represent programming to the user audience.
- Work with management to determine resource requirements for therapeutic area/department responsibilities.
- Review and select candidates; screen and interview for contractor and permanent roles; provide feedback on contributions, evaluate performance, and recommend yearly goals.
- Advise direct reports on retention procedures for data, records, and employee information.
Qualifications/requirements:
- Master’s Degree.
- 8–10 years of relevant work experience.
- SAS Certification desirable.
- Alternatively: 5+ years of programming experience processing clinical trial data in biotechnology/pharmaceutical/health industry, including some project and people management experience with a Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
Application instructions:
- Apply now.