Senior PK Analyst

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

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.

Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™