Offer summary

Qualifications:

Educated to degree level in a relevant discipline or equivalent work experience., Excellent analytical skills and knowledge of programming and reporting processes., Familiarity with SOPs/Guidelines, ICH-GCP, and applicable regulations., Competent in written and oral English with good communication skills..

Key responsibilities:

Perform statistical programming for assigned projects, ensuring high quality and value.

Produce low-medium complexity derived datasets, tables, figures, and data listings.

Maintain documentation for studies to ensure regulatory compliance and traceability.

Participate in audits and inspections, ensuring adherence to SOPs and guidelines.

Job description

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.

Job Description

Key Accountabilities:

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 low-medium complexity derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.

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.

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.

Skills:

Excellent analytical skills.
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.
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.

Knowledge and Experience: