Statistical Programmer II
Tasks
- Assist production and QC of derived dataset specifications
- Check own work for first-time quality
- Coordinate project start-up activities
- Create global programs
- Deliver statistical programming services
- Develop knowledge of SAS programming and procedures
- Ensure compliance with ICH/GCP
- Ensure compliance with SOPs and guidelines
- Maintain regulatory knowledge
- Maintain supporting documentation per SOPs and guidelines
- Participate in process and quality improvement
- Produce derived datasets, tables, figures, and data listings
- Provide training and mentorship
- Support audits and regulatory inspections
- Track project documentation
- Use efficient programming techniques for derived datasets
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
Education
N/A
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