Statistical Programmer II
India-Hyderabad-Remote
R
INR 850K-1100K (estimate) Mid-level Full Time
Tasks
- Assist in project start-up coordination
- Create derived datasets
- Deliver statistical programming services
- Ensure compliance with CDISC standards and electronic submissions requirements
- Ensure compliance with ICH-GCP and regulations
- Ensure first time quality through self review
- Generate tables figures and data listings
- Maintain regulatory knowledge
- Maintain supporting documentation per SOPs and guidelines
- Participate in internal external audits and inspections
- Participate in process and quality improvement
- Produce SDTM ADaM datasets
- Provide training and mentorship
- Support derived dataset specifications and process documents
- Track project documentation
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Electronic submissions | ICH GCP | Part 11 | Process Improvement | Project documentation | QC | Quality management | SAS | SDTM
Education
N/A
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