Principal Statistical Programmer
India-Hyderabad-Remote
R
INR 2000K-3800K (estimate) Senior-level Full Time
Tasks
- Assess technology and processes
- Coordinate project start up
- Coordinate statistical programming team
- Create global programs
- Develop dataset specifications
- Ensure compliance with ICH/GCP
- Ensure compliance with SOPs
- Fill statistical programming lead role
- Identify changes in scope
- Lead study delivery within timeline and budget
- Maintain derived dataset documentation
- Manage stakeholder communication
- Monitor resourcing and project budget
- Negotiate statistical programming timelines
- Participate in process quality improvement
- Perform data listing programming QC
- Perform dataset programming QC
- Perform figure programming QC
- Perform table programming QC
- Program ADaM datasets
- Program SDTM datasets
- Provide consultancy on statistical programming tasks
- Provide leadership and training
- Represent statistical programming on initiatives
- Resolve daily conduct problems
- Review database setup specifications
- Review mock shells
- Review statistical analysis plan
- Support internal and external audits
- Support sponsor technical issues
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical trial | Dataset programming | Electronic submissions | ICH GCP | Part 11 | Project Management | QC | Quality Control | SAS | SDTM | SOPs | Sprints | Stakeholder management
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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