Statistical Programmer II
Tasks
- Coordinate project start-up activities
- Create global programs and tracking spreadsheets
- Develop derived datasets
- Ensure compliance with SOPs and ICH-GCP
- Generate tables figures and data listings
- Maintain derived dataset specifications
- Maintain study supporting documentation
- Participate in internal external audits and regulatory inspections
- Participate in process and quality improvement initiatives
- Perform quality control on derived outputs
- Provide training and mentorship
- Support submission documentation QC
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Audit Support | CDISC | CFR Part 11 | Data Management | Electronic submissions | ICH GCP | Part 11 | Process Improvement | Quality Control | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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