Statistical Programmer II
Tasks
- Coordinate project start-up activities
- Create global program documentation
- Create tables figures and data listings
- Ensure 21 CFR Part 11 compliance
- Ensure ICH GCP compliance
- Generate SDTM and ADaM datasets
- Maintain supporting documentation per SOPs and guidelines
- Participate in audits and regulatory inspections
- Perform quality control on low to medium complexity outputs
- Produce derived datasets
- Provide training and mentorship on SAS processes
- Support derived dataset specification production and QC
- Track spreadsheets and required documentation
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | ICH GCP | Part 11 | SAS | SDTM
Education
N/A
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