Senior Statistical Programmer
India-Hyderabad-Remote
R
INR 2116K-3500K (estimate) Senior-level Full Time
Tasks
- Apply CDISC standards
- Coordinate statistical programming team delivery
- Create dataset specifications and process documents
- Create global programs
- Deliver derived datasets and QC results
- Ensure compliance with SOPs and ICH-GCP
- Lead process and quality improvement initiatives
- Lead statistical programming on projects
- Maintain study documentation traceability
- Monitor project resourcing and budgets
- Negotiate statistical programming timelines
- Participate in audits and regulatory inspections
- Perform quality control on derived dataset programming
- Produce and QC SDTM ADaM datasets
- Produce tables figures and data listings
- Provide consultancy for statistical programming tasks
- Review database setup specifications
- Review mock shells
- Review statistical analysis plans
- Support project start-up activities
- Support sponsor technical meetings
- Track project scope changes
- Train and mentor staff
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical trials | Electronic submissions | ICH GCP | Part 11 | Project Management | QC | S&OP | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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