Senior PK Analyst - R Programmer

Parexel is looking for a Senior PK Analyst to be remotely based but living in any of the countries listed below only. We are looking for a strong programmers with proficient experience in R and SAS.

About Parexel

• 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.

Responsibilities

• South Africa Poland Romania Serbia Croatia Lithuania Georgia Hungary Czech Republic 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.
• PK Analyst also provides support to other analysts including programming assistance, query resolution, mentoring and training.
• 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 programming experience using SAS and R (required) Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) AND R. (required) Advanced skills in Microsoft applications (required) Experience with Phoenix WinNonlin desireable
• Knowledge of pharmacokinetic data desireble
• Understand regulatory requirements concerning industry technical standards

Requirements

• 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.

Preferred

• Unix and/or Linux knowledge is advantageous.
• A bachelor’s degree or equivalent in a programming, statistics or mathematics discipline is preferable.
• Post graduate qualification is advantageous