Senior PK Analyst - R Programmer

Parexel

12d•Remote

About The Position

Parexel is seeking a Senior PK Analyst to work remotely while residing in one of the following countries: South Africa, Poland, Romania, Serbia, Croatia, Lithuania, Georgia, Hungary, or the Czech Republic. The role calls for strong programming skills and proficient experience in R and SAS. The Senior PK Analyst is a subject matter expert who provides technical support and expert advice to internal and external stakeholders, including sponsors and the Clinical Pharmacology, Modelling & Simulation (CPMS) team. The role derives pharmacokinetic (PK) and pharmacodynamic (PD) parameters and programs and validates NONMEM and PK/PD-derived datasets, as well as tables, listings, figures, and statistical appendices. The analyst works independently on clinical development projects of varying complexity and supports other analysts through programming assistance, query resolution, mentoring, and training.

Requirements

4–6 years of programming experience using SAS and R.
Expert knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH, and R.
Advanced skills in Microsoft applications.
Understanding of regulatory requirements concerning industry technical standards.
Ability to learn new systems and work in an evolving technical environment.
Professional attitude, self-motivation, and logical thinking.
Excellent attention to detail.
Excellent interpersonal, verbal, and written communication skills.
Strong project management skills.
Client-focused approach to work.
Ability to manage varied tasks, independently prioritize workload, and adapt flexibly to change.
Good standard of written and spoken English.
Ability to negotiate and influence to achieve results.
Ability to resolve complex issues creatively and effectively.
Ability to work under pressure and meet scheduled timelines.
Ability to work with line and middle management at a functional level.

Nice To Haves

Experience with Phoenix WinNonlin.
Knowledge of pharmacokinetic data.
Unix and/or Linux knowledge.
A bachelor's degree or equivalent in programming, statistics, or mathematics is preferable.
A postgraduate qualification is advantageous.

Responsibilities

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.
Perform activities according to agreed processes (SOPs) and timelines while maintaining quality.
Ensure deliveries match agreed specifications and expectations.
Apply good programming practices and follow International Conference on Harmonization and Good Clinical Practice standards.
Participate in and/or lead process and quality improvement initiatives.
Potentially serve as a process or system owner responsible for developing, implementing, and maintaining processes or systems in collaboration with stakeholder functions such as IT Technology and Quality.
Provide programming assistance, resolve queries, and mentor and train other analysts.
Work independently on clinical development projects of varying complexity and provide technical support and expert advice to stakeholders.