# PK/PD Statistical Programmer

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Frankfurt-Hesse-Germany/PK-PD-Statistical-Programmer_R1532189?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6d153e04-10b

## 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.

**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 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.

**Preferred Skills**

- 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.

## Skills

### Required
- R programming
- PK/PD datasets
- NONMEM dataset creation
- SDTM
- ADaM
- controlled terminology
- PK/PD principles
- clinical trial concepts

### Nice to have
- standardized workflows for NONMEM dataset creation
- R package testing
- validation frameworks
- reproducible programming practices
- pharmacometrics workflows

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Frankfurt-Hesse-Germany/PK-PD-Statistical-Programmer_R1532189?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)