Statistical Programmer II - SDTM

Description:

Project 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 :

- Maintain 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.

General :

- 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