Statistical Programmer II
Tasks
- Coordinate project start-up activities
- Create tables figures and data listings
- Develop derived datasets SDTM and ADaM
- Ensure compliance with SOPs guidelines ICH GCP and regulations
- Maintain supporting study documentation according to SOPs and guidelines
- Participate in internal and external audits and regulatory inspections
- Participate in process and quality improvement initiatives
- Perform QC of derived datasets tables figures and data listings low to medium complexity
- Produce and QC derived dataset specifications
- Provide training and mentorship on SAS and regulatory knowledge
- Track project documentation
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Data Listing | Electronic submissions | ICH GCP | Part 11 | Process Improvement | Project documentation | QC Documentation | Quality Control | Regulatory Compliance | SAS | SDTM
Education
N/A
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