Responsibilities:
- Provide timely support to the study team on all statistical programming matters according to project strategies.
- Provide project leadership and programming support for processing data from clinical studies; guide implementation and execution of programming and project standards.
- Lead programming for all programming deliverables through regulatory approval, product launch, data monitoring boards, and annual reports (internal or CROs).
- Oversee documentation and ensure consistent maintenance of code, logs, and output in a regulated environment; respond to senior-management statistical ad hoc requests.
- Develop expertise in a therapeutic area or standard tool; work with minimal supervision to prepare, execute, report, and document projects.
- Serve as lead programmer for development and QC of tables, listings, graphs, or systems using Regeneron tools/methodologies and CDISC SDTM/ADaM standards.
- Manage programming effort using tools to track, allocate, and summarize work progress and completion; support complex presentations and ad hoc requests.
- Act as programming representative in multidisciplinary study teams to support analysis and clinical trial reporting up to regulatory approval and annual reports.
- If applicable, lead application development and represent programming to the user audience.
- Work with management on resource requirements; review/select candidates and interview for contractor and permanent positions.
- Provide feedback on team contributions and recommend yearly goals; advise direct reports on retention of data, records, and information procedures.
Qualifications:
- Masterβs Degree.
- 8β10 years of relevant work experience.
- SAS Certification desirable.
- Alternatively: 5+ years programming experience processing clinical trial data in biotech/pharma/health industries, with some project and people management experience and a Masterβs in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline.