Senior PK Analyst

🕒 September 4

🌐 South Africa, Poland, +2 more countries – Remote

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⏰ Full Time

🟠 Senior

🧐 Analyst

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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.

📋 Description

• Provide technical support and expert advice to internal and external stakeholders, including sponsors and the Clinical Pharmacology, Modelling & Simulation (CPMS) team • Derive Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters • Program and validate NONMEM datasets and PK/PD derived datasets • Program and validate tables, listings, figures, and statistical appendices where applicable • Execute activities according to agreed SOPs and timelines while maintaining quality • Ensure deliveries match agreed specifications and expectations • Apply good programming practices according to International Conference on Harmonization and Good Clinical Practice standards • Participate in and/or lead process and quality improvement initiatives • Serve as process/system owner for development, implementation, and maintenance of processes/systems in collaboration with stakeholder functions • Support other analysts through programming assistance, query resolution, mentoring, and training • Work independently on clinical development projects of varying complexity

🎯 Requirements

• 4-6 years relevant experience • Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R or both; R is preferred • Experience with Phoenix WinNonlin or equivalent • Knowledge of pharmacokinetic data • Advanced skills in Microsoft applications • Understanding of regulatory requirements concerning industry technical standards • Unix and/or Linux knowledge is advantageous • Ability to learn new systems and function in an evolving technical environment • Professional attitude, self-motivated, logical thinking • Excellent attention to detail • Excellent interpersonal, verbal, and written communication skills • Strong project management skills • Client focused approach to work ethic • Ability to manage multiple and varied tasks, independently prioritize workload, and adapt to change • Good standard of written and spoken English • Ability to negotiate and influence to achieve results • Ability to resolve complex issues in creative and effective ways • Ability to work well under pressure and keep to scheduled timelines • Ability to work with line- and middle-management on a functional level • Bachelor's degree or equivalent in a programming, statistics or mathematics discipline is preferable • Post graduate qualification is advantageous

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