Senior PK Analyst
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.
Parexel is looking for a Senior PK Analyst to be remotely based but living in any of the following locations:
South Africa
Poland
Italy
Romania
The Senior PK Analyst is recognized as a subject matter expert, providing technical support and expert advice to internal and external stakeholders including sponsors and within the Clinical Pharmacology, Modelling & Simulation (CPMS) team. They are responsible for the derivation of Pharmacokinetic (PK), and Pharmacodynamic (PD) parameters including the programming and validation of NONMEM datasets, PK/PD derived datasets and tables, listings, figures, and statistical appendices. This person will be required to work independently on clinical development projects of all levels of complexity. The Senior PK Analyst also provides support to other analysts including programming assistance, query resolution, mentoring and training.
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.
Proactively participate in and/or lead process/quality improvement initiatives.
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)
Knowledge and Experience:
4-6 years relevant experience
Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R or both. However, R is preferred.
Experience with Phoenix WinNonlin or equivalent
Knowledge of pharmacokinetic data
Advanced skills in Microsoft applications
Understand regulatory requirements concerning industry technical standards
Unix and/or Linux knowledge is advantageous.
Skills:
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.
Education:
A bachelor’s degree or equivalent in a programming, statistics or mathematics discipline is preferable. Post graduate qualification is advantageous
Originally posted on Himalayas