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About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Flexible work arrangements
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
R programmingNONMEMPK/PD analysisdataset creationquality controlQC automationstatistical programmingdata processingSDTMADaM
Soft Skills
attention to detailanalytical skillsdocumentation skillscommunication skillsindependent workcollaborative work
Certifications
Bachelor’s degreeMaster’s degree