Senior PK Analyst

Parexel; Polska; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior PK Analyst to work remotely but be based in eligible locations internationally. The role requires expert PK/PD programming, NONMEM data handling, and strong collaboration with sponsors within CPMS. Ideal candidates have 4–6 years of PK experience and proficiency in SAS/R and Phoenix WinNonlin.

The position involves independent work on complex clinical projects, mentoring, and supporting other analysts while adhering to regulatory standards and SOPs.

Qualifications

• 4-6 years relevant experience.
• Expert knowledge of SAS (SAS/Base/STAT/GRAPH) or R.
• Experience with Phoenix WinNonlin.
• Knowledge of pharmacokinetic data.
• Advanced skills in Microsoft applications.
• Understand regulatory requirements.
• Unix/Linux knowledge advantageous.
• Good written and spoken English.

Responsibilities

• Derivation of PK and PD parameters.
• Programming and validation of NONMEM datasets and PK/PD derived datasets.
• Programming and validation of tables, listings, figures, and statistical appendices.
• Execute activities according to SOPs and timelines with high quality.
• Ensure deliveries match specifications and expectations.
• Participate in and/or lead process/quality improvement initiatives.

Skills

SAS

R

WinNonlin

MS Office

Regulatory knowledge

Unix/Linux

Attention to detail

Communication skills

Project management

English

Education

Bachelor's degree in programming/statistics/mathematics

Tools

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

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