Statistical Programmer I/II
Tasks
- Apply quality checks to ensure first time quality
- Coordinate project start-up activities
- Create derived datasets
- Deliver statistical programming services
- Ensure compliance with ICH GCP and 21 CFR Part 11
- Ensure compliance with SOPs and guidelines
- Generate SDTM and ADaM datasets
- Maintain and expand regulatory knowledge
- Maintain regulatory and technical documentation
- Participate in internal and external audits
- Participate in process and quality improvement initiatives
- Produce tables figures and data listings
- Provide training and mentorship
- Support derived dataset specifications production and QC
- Support regulatory inspections
- Track project documentation and spreadsheets
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Electronic submissions | ICH GCP | Part 11 | QC | SAS | SDTM | SOPs
Education
N/A
Roles
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