Statistical Programmer II

January 31

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Parexel

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Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• The Statistical Programmer II provides technical expertise for the conduct of clinical trials. • Work with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. • Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. • Deliver high quality service, checking own work in an ongoing way to ensure first-time quality. • Produce derived datasets, tables, figures, and data listings of any complexity. • Maintain and expand local and international regulatory knowledge within the clinical industry. • 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 regulatory compliance. • Ensure compliance with SOPs/Guidelines, ICH-GCP, 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.

🎯 Requirements

• Competent in written and oral English. • Good communication 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.