27 May 2026

Principal Statistical Programmer (PK/PD) (m/w/d)

IQVIA

Amsterdam

27 May 2026

Apply

Principal Statistical Programmer (PK/PD) needed at IQVIA for remote role based in Amsterdam. Lead development of CDISC-compliant datasets and support early-phase clinical trials. Requires 8+ years of statistical programming experience and expert SAS skills.

RemoteFull-timePrincipalSASCDISC

Principal Statistical Programmer (PK/PD) (m/w/d)

Apply

RemoteFull-timePrincipalSAS

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

8 years

Employment Type

Full-time

Experience Level

Principal

Core Qualifications

Technical (Must-have)

SASCDISCSDTMADaMTLFPK/PDPopPKExposure-Response

Soft Skills

communicationstakeholder managementindependent workdetail-oriented

Key Responsibilities

•Lead the development and validation of CDISC-compliant datasets (SDTM, ADaM) and Tables, Listings, and Figures (TLFs).
•Design and implement PK, PK/PD, and safety ADaM datasets, ensuring compliance with industry standards and regulatory requirements.
•Support Population PK (PopPK), PK/PD, and Exposure–Response (ER) analyses by developing and maintaining analysis-ready datasets.
•Collaborate closely with Clinical Pharmacology, Biostatistics, and Translational Medicine teams to support early-phase decision-making.
•Provide programming leadership for Phase I / First-in-Human trials, crossover designs, and PK parameter pooling strategies.
•Contribute to regulatory submissions, ensuring datasets and outputs meet global health authority standards (e.g., FDA, EMA).
•Develop and maintain standard programming practices, macros, and QC processes to enhance efficiency and quality.
•Act as a technical lead or SME, mentoring junior programmers and guiding project delivery.
•Ensure adherence to timelines, quality standards, and documentation requirements.
•Support integrated analyses and pooled PK datasets across studies where required.

Principal Statistical ProgrammerPK/PDSASCDISCSDTMADaMClinical ResearchPharmaceuticalRemoteFull-time

Key Responsibilities

•Lead the development and validation of CDISC-compliant datasets (SDTM, ADaM) and Tables, Listings, and Figures (TLFs).

•Design and implement PK, PK/PD, and safety ADaM datasets, ensuring compliance with industry standards and regulatory requirements.

•Support Population PK (PopPK), PK/PD, and Exposure–Response (ER) analyses by developing and maintaining analysis-ready datasets.

•Collaborate closely with Clinical Pharmacology, Biostatistics, and Translational Medicine teams to support early-phase decision-making.

•Provide programming leadership for Phase I / First-in-Human trials, crossover designs, and PK parameter pooling strategies.

•Contribute to regulatory submissions, ensuring datasets and outputs meet global health authority standards (e.g., FDA, EMA).

•Develop and maintain standard programming practices, macros, and QC processes to enhance efficiency and quality.

•Act as a technical lead or SME, mentoring junior programmers and guiding project delivery.

•Ensure adherence to timelines, quality standards, and documentation requirements.

•Support integrated analyses and pooled PK datasets across studies where required.