Principal Statistical Programming Lead - Hyderabad/Bangalore/Mumbai
IN022 Hyderabad, India
INR 2500K-3500K (estimate) Senior-level Full Time
Tasks
- Adopt new processes and technology
- Coordinate and oversee programming team activities
- Design and develop clinical programming solutions
- Ensure ICH GCP and 21 CFR Part 11 compliance
- Ensure analysis dataset design consistency across trials
- Implement data and analysis standards
- Manage escalations independently
- Manage training compliance and development plans
- Oversee outsourced programming activities
- Plan and deliver programming activities for clinical projects
- Provide mentorship and coaching
- Provide technical guidance to programming teams
- Review project requirements and documentation
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Analysis standards | Analysis systems | CDISC | CFR Part 11 | Clinical data | Clinical data management | Clinical trials | Compliance Management | Data Management | Data Privacy | Data Structures | Data and Analysis Standards | ICH GCP | Part 11 | Program Management | Python | Quality Assurance | R | Risk Management | SAS | Standard Operating Procedure | Statistical Analysis | Statistical Analysis Systems | Team Management
Education
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