Job Summary
The Senior Manager will lead statistical programming for clinical studies, guiding the production of accurate, high-quality deliverables that meet CDISC standards. Working with colleagues across functions, this role supports the development of programming specifications and coordinates CRO work to help ensure clinical data and analyses are prepared for regulatory submissions.
Responsibilities
- Lead statistical programming activities supporting clinical studies.
- Ensure programming deliverables are high quality and compliant with applicable CDISC standards.
- Collaborate cross-functionally to create and refine programming specifications.
- Oversee CRO programming activities in support of regulatory submissions.
Qualifications
- Master’s degree or higher in a relevant discipline.
- At least 6 years of experience in the pharmaceutical or biotechnology industry.
- Strong technical proficiency in SAS.
- In-depth knowledge of clinical trial regulatory requirements.
