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Statistical Programmer II

Parexel

- Remote (India)
- 20h ago

Key Accountabilities 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.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.

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 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).

Skills

- Excellent analytical skills.
- Proficiency in SAS.
- Knowledge and understanding of the programming and reporting process.
- Knowledge of SOPs/Guidelines, ICH-GCP,



and any other applicable local and international regulations such as 21 CFR Part 11.
- Ability to learn new systems and function in an evolving technical environment.
- Ability to manage competing priorities and flexibility to change.
- Attention to detail.
- Ability to successfully work as part of a global team.
- Work effectively in a quality-focused environment.
- Effective time management in order to meet daily metrics or team objectives.
- Show commitment to and perform consistently high quality work.
- Business/operational skills that include customer focus, commitment to quality management, and problem solving.

Knowledge And Experience

- Competent in written and oral English.
- Good communication skills.

Education

- Educated to degree level in a relevant discipline and/or equivalent work experience.

Parexel

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