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.

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.

PK/PD Statistical Programmer – homebased

Key skills