PK/PD Statistical Programmer – homebased
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Job Description
PK/PD Statistical Programmer enhancing dataset quality through advanced R programming at IQVIA. Collaborating with cross-functional teams to ensure data accuracy across clinical trials.
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.
Requirements:
- 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:
- Health insurance
- Professional development opportunities
- Flexible work hours
- Remote work options
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