Statistical Programmer II

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.