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About the role
- Manager Statistical Programming providing programming support for clinical trial data at Regeneron. Leading project deliverables from development to regulatory approval and product launch with a multidisciplinary team.
Responsibilities
- Provide timely support to the study team on all programming matters according to project strategies.
- Lead the programming aspect of a project, both internally or CROs, for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards and annual reports.
- Oversee documentation and ensure consistent maintenance of code, logs, and output within a regulated environment.
- Meet statistical ad hoc requests of senior management.
- Develop an expertise within a therapeutic area or standard tool.
- Work with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting, and documentation of a project.
- Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements utilizing Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM).
- Manage the effort, including esubmission deliverables, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables.
- Provide programming support for complex presentations and more complex statistical ad-hoc requests.
- Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.
- Review and select resumes, screen and interview candidates for contractor and permanent positions.
- Advise all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.
Requirements
- Master’s Degree
- 8-10 years of relevant work experience
- SAS Certification desirable. Also acceptable - 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health-related industry, including some project and people management experience with a Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.
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) for eligible employees at all levels!
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