Senior PK Analyst

Parexel; South Africa; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Parexel is seeking a Senior PK Analyst to be remotely based, working within the Clinical Pharmacology, Modelling & Simulation (CPMS) team. The role involves deriving PK/PD parameters, programming and validating NONMEM datasets, and preparing PK/PD datasets, tables, listings, and figures.

4–6 years of relevant PK/PD experience is required, with expert SAS/R knowledge and familiarity with Phoenix WinNonlin. Strong communication and project management skills are essential.

Qualifications

• 4–6 years relevant experience in PK/PD analytics.
• Expert knowledge of SAS (SAS/BASE, SAS/STAT, SAS/GRAPH) or R.
• Experience with NONMEM datasets and PK/PD derived datasets.
• Proficiency in programming and validation of tables/listings/figures.
• Familiarity with regulatory and ICH/GCP standards.

Responsibilities

• Derivation of PK/PD parameters and data outputs.
• Programming and validation of NONMEM datasets and PK/PD data.
• Create tables/listings/figures and statistical appendices.
• Adhere to SOPs, timelines and quality standards.
• Mentor peers and provide programming support as needed.
• Lead process/system improvements with stakeholders.
• Support IT/Quality collaboration for process ownership.

Skills

SAS/R

PK/PD analysis

NONMEM

Phoenix WinNonlin

Unix/Linux

MS Office

Regulatory knowledge

English communication

Project management

Education

Bachelor in programming, statistics or mathematics

Postgraduate qualification advantageous

Tools

SAS

R

Phoenix WinNonlin

Job description

Parexel is looking for a Senior PK Analyst to be remotely based but living in any of the following locations:

• 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. 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