Statistical Programmer I
Tasks
- Coordinate project start-up activities
- Deliver statistical programming for assigned projects
- Ensure compliance with SOPs guidelines ICH GCP and regulations
- Follow regulatory requirements for CDISC and electronic submissions
- Maintain and expand regulatory knowledge
- Maintain supporting documentation in accordance with SOPs and guidelines
- Participate in internal external audits and regulatory inspections
- Participate in process quality improvement initiatives
- Produce derived datasets QC tables figures and data listings
- Provide training and mentorship
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | CDISC | CFR Part 11 | ICH GCP | Part 11 | QC | SAS
Education
N/A
Roles
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