Statistical Programmer II - SDTM
Parexel International India Pvt. Ltd.Hyderabad9 hours ago
Job descriptionMaintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes / procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. Maintain all supporting documentation for studies in accordance with SOPs / Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs / Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal / external audits and regulatory inspections as required
Management :
- Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
- Statistical Programming For Assigned Projects
- Deliver best value and high quality service.
- Check own work in an ongoing way to ensure first-time quality.
- Use efficient programming techniques to produce derived datasets (e. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
- Assist in the production / QC of derived dataset specifications and other process supporting documents and submission documentation.
Training :
General :
(ref : hirist.tech)
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Statistical Programmer • Hyderabad