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Manager of Statistical Programming
Job Summary
A company is looking for a Manager of Statistical Programming.
Key Responsibilities
- Oversee the planning and execution of the statistical programming team's projects
- Develop and maintain programming specifications and create submission-ready SDTM and ADaM datasets
- Collaborate with cross-functional teams to ensure timely and high-quality deliverables
Required Qualifications
- Bachelor's degree or equivalent work experience preferred
- 10+ years of experience in the Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
- Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies
- Experience in SAS programming, including base SAS, Proc SQL, and macro programming
- Knowledge of CDISC data models like SDTM and ADaM
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COMPLETE JOB DESCRIPTION
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