Senior Manager, Statistical Programming
Regeneron
2 hours ago
On-site
Warren, NJ
Clinical Research and Development
Responsibilities
- Provide technical leadership and programming support for statistical programming matters per project strategies within therapeutic areas.
- Manage programming deliverables from single study through regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests.
- Oversee documentation and maintain consistent code, logs, and output in a regulated environment.
- Lead and coordinate programming documentation/specifications for multiple studies following programming standards.
- Communicate proactively with study/project teams to clarify requirements and specifications; guide direct reports/support programmers on assignment status.
- Lead and support global regulatory authority submissions by preparing programming deliverables and addressing health authority requests with partnering functions.
- Lead and manage department goals and SME topics; may set goals and manage performance/training needs, development plans, mentoring, and coaching.
- May participate in screening and interviewing candidates.
Qualifications / Required
- MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 10+ (12+) years programming experience, preferably clinical trial data processing in biotech/pharma/health, including some project/people management.
Skills / Preferred
- Advanced SAS programming in a clinical data environment; expertise in at least one (preferably multiple) therapeutic areas.
- Knowledge of other languages (R, Python) is a plus.
- Understanding of pharmaceutical clinical development and regulatory submissions/requirements.
- Ability to work on global interdisciplinary teams; strong organizational/interpersonal/communication/leadership skills.
Benefits (if applicable)
- Health/wellness programs, 401(k) match, equity awards, annual bonus, paid time off, paid leaves (location-dependent; U.S. examples provided).
Application Instructions
- “Apply now.”
- Provide technical leadership and programming support for statistical programming matters per project strategies within therapeutic areas.
- Manage programming deliverables from single study through regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests.
- Oversee documentation and maintain consistent code, logs, and output in a regulated environment.
- Lead and coordinate programming documentation/specifications for multiple studies following programming standards.
- Communicate proactively with study/project teams to clarify requirements and specifications; guide direct reports/support programmers on assignment status.
- Lead and support global regulatory authority submissions by preparing programming deliverables and addressing health authority requests with partnering functions.
- Lead and manage department goals and SME topics; may set goals and manage performance/training needs, development plans, mentoring, and coaching.
- May participate in screening and interviewing candidates.
Qualifications / Required
- MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 10+ (12+) years programming experience, preferably clinical trial data processing in biotech/pharma/health, including some project/people management.
Skills / Preferred
- Advanced SAS programming in a clinical data environment; expertise in at least one (preferably multiple) therapeutic areas.
- Knowledge of other languages (R, Python) is a plus.
- Understanding of pharmaceutical clinical development and regulatory submissions/requirements.
- Ability to work on global interdisciplinary teams; strong organizational/interpersonal/communication/leadership skills.
Benefits (if applicable)
- Health/wellness programs, 401(k) match, equity awards, annual bonus, paid time off, paid leaves (location-dependent; U.S. examples provided).
Application Instructions
- “Apply now.”