Senior Manager, Statistical Programming
Job Summary
To support ongoing clinical studies, the full-time Senior Manager, Statistical Programming will lead programming activities, develop documentation, and ensure compliance with CDISC standards in a remote/hybrid work environment.
Key responsibilities
- Lead statistical programming activities for therapeutic areas, ensuring timely and high-quality deliverables
- Develop and maintain programming documentation, including CDISC standard SDTM and ADaM specifications
- Support global regulatory submissions and collaborate with internal and external stakeholders to address health authority requests
Required qualifications
- Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline
- 10+ years of programming experience in processing clinical trial data within the biotechnology or pharmaceutical industry
- Proficiency in SAS programming; knowledge of R or Python is a plus
- Excellent understanding of pharmaceutical clinical development and regulatory submissions
- Experience in implementing CDISC standards and managing programming processes
Complete Job Description
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