Senior PK/PD Statistical Programmer - R and NONMEM Expert

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

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.