PK/PD Statistical Programmer (m/w/d) - homebased

IQVIA; Dublin; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

IQVIA seeks an experienced PK/PD Statistical Programmer to deliver NONMEM-ready PK/PD datasets using SDTM/ADaM standards with advanced R skills. You will create high-quality datasets for pre- and post-lock data and perform QC across pharmacometrics workflows.

Join a global team supporting regulatory submissions, data management, and biostatistics with a strong emphasis on data quality and process standardization.

Competenze

• 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 for PK/PD analyses.
• Strong understanding of SDTM, ADaM, and controlled terminology; PK/PD principles and clinical trial concepts.

Mansioni

• 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; execute programming tasks of medium to high complexity with accuracy and timeliness.
• Perform QC of NONMEM datasets and provide deliverables for regulatory submissions.
• QC of customized R packages used for pharmacometrics workflows; enhance automated test suites where needed.
• Liaise with Data Management, Biostatistics, Statistical Programming, and Bioanalytical groups to resolve data issues.

Conoscenze

Pharmacometric analysis

Statistical programming

SDTM/ADaM knowledge

Data QC automation

Scientific communication

Cross-functional collaboration

Formazione

Bachelor’s or Master’s degree in health, science, IT, mathematics, or related field

Strumenti

R

NONMEM

Descrizione del lavoro

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.