Statistical Programmer II

Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

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.g. 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.

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.

Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator 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.

Proactively participate in process/quality improvement initiatives.

Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).