Senior PK Analyst - R Programmer Parexel Remote · GA Pay not posted GCP

PharmoniQ; Georgia; Remote; USD 110,000 - 160,000; Full time

Job summary

Parexel is seeking a Senior PK Analyst to join our Clinical Pharmacology, Modelling & Simulation team. This role is remote-based, with eligibility to live in listed countries, requiring strong R and SAS skills to derive PK/PD parameters and to program and validate NONMEM datasets and related outputs.

You will work independently on clinical development projects of varying complexity and provide programming support, mentoring, and training to peers while ensuring high-quality deliveries in

Qualifications

• 4-6 years programming experience using SAS and R
• Expert knowledge of SAS (BASE/STAT/GRAPH) and R
• Advanced skills in Microsoft applications
• Experience with Phoenix WinNonlin desirable
• Knowledge of pharmacokinetic data desirable
• Understand regulatory requirements concerning industry technical standards
• Unix and/or Linux knowledge is 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 the agreed processes (SOP's) and timelines while maintaining good quality.
• Ensure that the deliveries match the agreed specifications and expectations.
• Apply good programming practices; work according to ICH and Good Clinical Practice standards.
• Proactively participate in and/or lead process/quality improvement initiatives.

Skills

SAS

R

Attention to detail

Interpersonal skills

Project management

English proficiency

Education

Bachelor's degree in programming, statistics or mathematics

Tools

Phoenix WinNonlin

Job description

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.

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

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