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 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.
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