Statistical Programmer II Guangzhou

When our values align, there's no limit to what we can achieve.

At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.

Originally posted on Himalayas