Senior PK/PD Statistical Programmer (R, NONMEM)

IQVIA Inc; Paris; On-site; EUR 70,000 - 110,000; Full time

Job summary

IQVIA Inc. is seeking an experienced PK/PD Statistical Programmer in Paris to develop and validate NONMEM-ready PK/PD datasets using SDTM/ADaM standards. You will process data from early to post-lock analyses with high accuracy and deliver compliant datasets for regulatory submissions.

The role demands expert R skills, strong PK/PD knowledge, and the ability to work across global teams, ensuring meticulous data quality and robust QC automation.

Qualifications

• Bachelor’s or Master’s degree in a health, science, IT, mathematics, or related field.
• Minimum 6 years of industry experience in clinical data analysis, statistical programming, or pharmacometrics support.
• Expert-level proficiency in R for data processing, dataset creation, and QC automation.
• Hands-on experience creating NONMEM datasets, including complex data structures for PK/PD analyses.
• Strong understanding of SDTM, ADaM, and controlled terminology.
• Applied knowledge of PK/PD principles and clinical trial concepts.
• High attention to detail with strong analytical, documentation, and communication skills.
• Ability to work independently and collaboratively across global, cross-functional teams.

Responsibilities

• Program, validate, and deliver NONMEM-ready PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills.
• Create high-quality PK/PD datasets for both pre-lock and post-lock clinical data.
• Independently execute programming tasks of medium to high complexity with excellent accuracy and timeliness.
• Critically review data, identify inconsistencies or gaps, and propose solutions to improve dataset quality and programming efficiency.
• Perform quality control (QC) of NONMEM datasets, including those produced by external partners.
• Support preparation of Deliverables for regulatory submissions following internal Pharmacometrics guidelines.
• Conduct QC of customized R packages used for pharmacometrics workflows; enhance or build automated test suites where needed.
• Liaise with cross-functional teams including Data Management, Biostatistics, Statistical Programming, and Bioanalytical groups to resolve data issues and ensure alignment.
• Adhere to relevant SOPs, working instructions, and regulatory standards; maintain inspection readiness.
• Contribute as a technical driver in the development and improvement of new PM standardization initiatives related to dataset creation and QC.

Skills

R programming

PK/PD datasets

NONMEM dataset creation

SDTM

ADaM

PK/PD principles

Data quality review

Documentation

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in health/science/IT/math

Tools

SQL

R packages testing/validation

Job description

IQVIA Inc. is seeking an experienced PK/PD Statistical Programmer in Paris to develop and validate NONMEM-ready PK/PD datasets using SDTM/ADaM standards. You will process data from early to post-lock analyses with high accuracy and deliver compliant datasets for regulatory submissions.

The role demands expert R skills, strong PK/PD knowledge, and the ability to work across global teams, ensuring meticulous data quality and robust QC automation.