Senior PK Analyst - R Programmer

Parexel; Athens (GA); Remote; USD 41,000 - 55,000; Full time

Job summary

Parexel is seeking a Senior PK Analyst to work remotely while based in the Czech Republic. The role involves derivation of PK/PD parameters, programming and validation of NONMEM datasets, and creation of tables, listings, figures, and statistical appendices.

The candidate will independently manage clinical development projects of varying complexity, mentor peers, and ensure adherence to SOPs and quality standards. Strong SAS and R expertise and English proficiency are required.

Qualifications

• 4-6 years programming experience using SAS and R (required).
• Expert knowledge of SAS (SAS/BASE, SAS/STAT, SAS/GRAPH) AND R.
• Good English proficiency for written and spoken communication.

Responsibilities

• Programming and validation of NONMEM datasets and PK/PD derived datasets.
• Programming and validation of tables, listings, figures, and statistical appendices.
• Execute activities per SOPs and timelines with high quality.
• Apply good programming practices; adhere to ICH and GCP standards.
• Lead process/quality improvement initiatives where appropriate.
• May serve as process/system owner in collaboration with IT/Quality.

Skills

SAS

R

English

Education

Bachelor's degree in programming, statistics or mathematics

Job description

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.

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.

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.

• 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.
• 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)
• 4-6 years programming experience using SAS and R (required)
• ~ Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) AND R. (Advanced skills in Microsoft applications (required)
• ~ Knowledge of pharmacokinetic data desireble
• ~ Understand regulatory requirements concerning industry technical standards
• ~ Unix and/or Linux knowledge is advantageous.
• Strong project management skills
• Good standard of written and spoken English
• Ability to resolve complex issues in creative and effective ways.
• A bachelor’s degree or equivalent in a programming, statistics or mathematics discipline is preferable. Post graduate qualification is advantageous