PK/PD Statistical Programmer (Remote)

Job summary

An experienced PK/PD Statistical Programmer is needed to support Pharmacometrics by producing high-quality datasets for modeling and analysis. The role involves ensuring data accuracy from early through post-lock clinical data, utilizing strong R programming skills and a solid understanding of PK/PD principles.

Qualifications

• Bachelor’s or Master’s degree in health, science, IT, mathematics, or a related field.
• Minimum of 6 years of industry experience in clinical data analysis, statistical programming, or pharmacometrics support.
• Expert-level proficiency in R for data processing and dataset creation.
• Hands-on experience with NONMEM dataset creation and complex data structures for PK/PD analyses.
• Strong understanding of SDTM, ADaM, and controlled terminology.
• High attention to detail with strong analytical, documentation, and communication skills.
• Ability to work independently and collaboratively across global teams.

Responsibilities

• Program, validate, and deliver NONMEM-ready PK/PD datasets based on SDTM/ADaM standards.
• Create high-quality PK/PD datasets for both pre-lock and post-lock clinical data.
• Execute programming tasks of medium to high complexity with accuracy and timeliness.
• Review data critically, identify inconsistencies, and propose solutions to improve dataset quality.
• Perform quality control (QC) of NONMEM datasets, including those from external partners.
• Support the preparation of deliverables for regulatory submissions.
• Conduct QC of customized R packages used for pharmacometrics workflows.
• Liaise with cross-functional teams to resolve data issues and ensure alignment.
• Adhere to relevant SOPs and maintain inspection readiness.
• Contribute to the development of new PM standardization initiatives.

Skills

• Experience building or enhancing standardized workflows for NONMEM dataset creation and QC.
• Familiarity with R package testing and validation frameworks.
• Knowledge of pharmacometrics workflows in clinical or real-world settings.

Education

• Bachelor’s or Master’s degree in a relevant field.

Tools

• R programming, NONMEM, SDTM, ADaM.