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.