Senior PK Analyst - R Programmer

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior PK Analyst to join the Clinical Pharmacology, Modelling & Simulation (CPMS) group. This is a remote role based in the United States with eligibility for professionals in listed countries; you will develop PK/PD datasets, NONMEM outputs, and related tables/listings/figures.

The role requires strong SAS and R programming, with expert knowledge, and a solid foundation in ICH-GCP standards. Collaboration with sponsors and internal teams is essential.

Qualifications

• Bachelor's degree in programming, statistics or mathematics; post graduate preferred.
• 4–6 years programming experience using SAS and R (required).
• Expert knowledge of SAS (BASE/STAT/GRAPH) and R (required).
• Advanced skills in Microsoft Office applications (required).
• Experience with Phoenix WinNonlin desirable.
• Knowledge of pharmacokinetic data desirable.
• Understand regulatory requirements for industry technical standards.
• Unix and/or Linux knowledge advantageous.

Responsibilities

• 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 SOPs and timelines while maintaining quality.
• Ensure deliveries match specifications and expectations.
• Apply good programming practices; adhere to ICH-GCP standards.
• Proactively participate in process/quality improvement initiatives.
• May serve as process/system owner with IT/Quality collaboration.

Skills

SAS programming

R programming

Regulatory knowledge

Attention to detail

Education

Bachelor's degree in programming, statistics or mathematics

Postgraduate qualification advantageous

Tools

SAS (BASE/STAT/GRAPH)

R

Phoenix WinNonlin

UNIX/Linux

Microsoft Office

Job description

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.

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.

• 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 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
• 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