Statistical Programmer I
Tasks
- Contribute to process and quality improvement
- Coordinate project start-up activities
- Develop derived datasets
- Ensure compliance with ICH GCP and 21 CFR Part 11
- Maintain supporting documentation in accordance with SOPs and guidelines
- Participate in internal external audits and regulatory inspections
- Perform QC for derived datasets tables figures data listings
- Produce SDTM ADaM tables figures data listings
- Support production and QC of derived dataset specifications
- Train and mentor staff on regulatory knowledge and SAS
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Data Quality | Data quality control | Electronic submissions | ICH GCP | Part 11 | Process Improvement | Project documentation | Quality Control | Quality management | Regulatory Compliance | SAS | SDTM
Education
N/A
Roles
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