Statistical Programmer II
Tasks
- Comply with ICH GCP
- Coordinate project start-up activities
- Create global programs
- Create tables figures and data listings
- Deliver statistical programming services
- Develop SAS knowledge and processes in other functional areas
- Ensure compliance with SOPs and guidelines
- Ensure first time quality by checking own work
- Generate ADaM
- Generate SDTM
- Maintain regulatory knowledge
- Maintain supporting study documentation
- Participate in internal and external audits
- Participate in process and quality improvement
- Participate in regulatory inspections
- Perform quality control on low medium complexity outputs
- Produce derived datasets
- Provide training and mentorship to staff and teams
- Support production and quality control of derived dataset specifications
- Track required project documentation
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
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