About this role
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:
• Derivation of Pharmacokinetic (PK), and Pharmacodynamic (PD) parameters. • Programming and validation of NONMEM datasets and PK/PD derived datasets. • Programming and validation of tables, listings, figures, and statistical appendices if applicable. • Execute activities according to the agreed processes (SOP’s) and timelines while maintaining good quality. • Ensures that the deliveries match the agreed specifications and expectations. • Apply good programming practices; works according to International Conference on Harmonization and Good Clinical Practice standards. • Provides training and guidance and act as a mentor to less experienced analysts. • Checks own work and the work of others to ensure first-time quality. • Maintain a positive, results orientated work environment, building partnerships, and promoting teamwork • Proactively participate in and/or lead process/quality improvement initiatives. • Represent CPMS on cross-functional initiatives • Lead knowledge sharing forums and proactively support the development of the wider department. • May serve as process/system owner responsible for development, implementation and maintenance of process/systems in collaboration with key stakeholder functions (e.g. IT Technology, Quality)
Skills:
• Expert programming skills (with a focus on SAS or R programming). • Advanced skills in Microsoft applications (Word, Excel, PowerPoint, Outlook) • 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 with enthusiasm and independently prioritize workload, demonstrated flexibility to change. • Good standard of written and spoken English • Ability to negotiate and influence to achiever results. • Ability to resolve complex issues in creative and effective ways. • Ability to work well under pressure and to keep to scheduled timelines. • Ability to work with line- and middle-management on a functional level.
Knowledge and Experience:
• 4-6 years relevant experience • Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R or both • Experience with Phoenix WinNonlin or equivalent • Knowledge of pharmacokinetic data • Understand regulatory requirements concerning industry technical standards
Education:
• A bachelor’s degree or equivalent in a programming, statistics or mathematics discipline is preferable. Post graduate qualification is advantageous