Senior Manager, Statistical Programming
Skills
- Excellent SAS Software Programming skills
- Strong understanding of clinical trial processes
- Extensive knowledge of CDISC standards
- Strong working knowledge of FDA & ICH/GCP regulations
Responsibilities
- Lead statistical programming and regulatory submission activities
- Manage CROs to meet timelines and expectations of quality
- Collaborate with other functions for clarity and consistency in CRFs
- Create and validate SDTM, ADaM, and TLFs
- Write and review data specifications of SDTM and ADaM datasets
Education
- BS in Statistics, Biostatistics, Engineering, Computer science or equivalent
Benefits
- Inclusive work environment
- Equal opportunity employer
Average salary estimate
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