IQVIA
clinical research services, commercial insights and healthcare intelligence
PK/PDStatisticalProgrammer(m/w/d)
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“PK/PD Statistical Programmer (m/w/d) at IQVIA. Skills: R programming, NONMEM dataset creation, PK/PD principles. 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”
What You'll Achieve.
producing high‑quality, compliant datasets for modeling and analysis; ensuring accuracy from early (unclean) through post‑lock clinical data; maintain inspection readiness
Industry & Context.
problem-solving skills; propose solutions to improve dataset quality and programming efficiency
What They're Looking For.
Must Have
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, understanding of SDTM, ADaM, and controlled terminology, Applied knowledge of PK/PD principles and clinical trial concepts, High attention to detail with analytical, documentation, and communication skills, Ability to work independently and collaboratively across global, cross-functional teams
Nice to Have
Experience building or enhancing standardized workflows for NONMEM dataset creation, submission packages, and QC, Experience with R package testing, validation frameworks, or reproducible programming practices, Familiarity with pharmacometrics workflows in clinical or real-world settings
What You'll Do.
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 enhance or build automated test suites where needed
Contribute as a technical driver in the development and improvement of new PM standardization initiatives related to dataset creation and QC
How You'll Work.
Team & Collaboration
Liaise with cross‑functional teams including Data Management, Biostatistics, Statistical Programming, and Bioanalytical groups to resolve data issues and ensure alignment; Ability to work collaboratively across global, cross‑functional teams
Communication Scope
communication skills
Full Job Description
* We are seeking an experienced **PK/PD Statistical Programmer** with strong experience in **R programming** , **PK/PD datasets** , and **NONMEM dataset creation**. This role supports Pharmacometrics by producing high‑quality, compliant datasets for modeling and analysis, ensuring accuracy from early (unclean) through post‑lock clinical data. The ideal candidate brings deep technical expertise, strong problem‑solving skills, and a solid understanding of PK/PD principles. ## **Key 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. ## **Required 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 profic
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