Statistical Programmer I
Tasks
- Coordinate project start-up activities
- Create project documentation and tracking spreadsheets
- Create tables figures and data listings
- Ensure compliance with ICH GCP and 21 CFR Part 11
- Maintain supporting documentation according to SOPs and guidelines
- Participate in internal and external audits and regulatory inspections
- Perform quality control on derived datasets tables figures and listings
- Produce and quality control derived dataset specifications
- Program derived datasets
- Support process and quality improvement initiatives
- Train and mentor staff and project teams
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | ICH GCP | Part 11 | QC | S&OP | SAS | SDTM
Education
N/A
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