Senior Principal Statistical Programmer
Merck Group · Hyderabad, Andra Pradesh, IN, 500003 ·
- Seniority
- Principal
The Senior Principal Statistical Programmer leads statistical programming initiatives for clinical trials, ensuring CDISC compliance and coordinating deliverables with CROs. The role involves directing complex programming tasks, managing process improvements, and providing technical leadership for submission readiness.
- Apply standards consistently
- Coordinate data management and clinical operations database specifications
- Coordinate outsourced statistical programming deliverables
- Direct complex trial project programming tasks
- Ensure CDISC compliance
- Ensure deliverable timelines and quality expectations
- Ensure quality planning execution monitoring control closure
- Ensure technical readiness for submission
- Guide project teams on statistical programming activities
- Implement statistical programming best practices
- Lead statistical programming biostatistics initiatives
- Manage continuous process improvements
- Maximize data integratability and interpretability
- Prioritize work with CRO
- Proactively plan project level statistical programming activities
- Provide statistical programming leadership
- Support inspections and audits documentation traceability