Statistical Programmer II
Tasks
- Coordinate project start-up activities
- Develop derived datasets
- Develop knowledge of SAS processes
- Ensure compliance with ICH-GCP and regulations
- Maintain derived dataset specifications
- Maintain study documentation in accordance with SOPs
- Participate in audits and regulatory inspections
- Perform quality control on derived datasets
- Produce tables figures and data listings
- Support process and quality improvement initiatives
- Train and mentor staff on regulatory knowledge
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
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
Roles
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