Manager of Statistical Programming
Job Summary
Overseeing statistical programming activities for clinical trials, the full-time Manager of Statistical Programming will provide technical leadership, ensure compliance with regulatory standards, and collaborate with cross-functional teams in a remote environment.
Key responsibilities:
- Lead statistical programming activities for assigned clinical studies, ensuring timely and high-quality deliverables
- Develop and implement departmental SOPs, programming standards, and reusable programming tools
- Coordinate programming activities with CROs and external partners to maintain quality and efficiency
Required qualifications:
- Minimum of eight years of statistical programming experience in the pharmaceutical or biotechnology industry
- Strong proficiency in SAS programming and knowledge of CDISC standards, including SDTM and ADaM
- Experience with clinical trial programming documentation and regulatory submission processes
- CRO/vendor oversight experience is preferred
- Familiarity with programming efficiency initiatives and tools such as Pinnacle 21 is a plus
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