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

Frankfurt/Main, Germany \| Full time \| Home\-based \| R1544617

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.

Required Skills \& Experience

Technical Skills

• Expert\-level proficiency in SAS programming.


• Strong hands\-on experience with CDISC standards (SDTM, ADaM) and TLF generation.


• Proven experience in developing:

+ Safety datasets
+ PK and PK/PD ADaM datasets

• Experience supporting PopPK / PK/PD / Exposure–Response workflows.


• Solid understanding of early\-phase clinical trial designs, including:

+ Phase I / First\-in\-Human (FIH) studies
+ Crossover studies
+ Exposure–response analysis
+ PK parameter pooling

Experience

• 8\+ years of statistical programming experience in a pharmaceutical or CRO environment.


• Demonstrated experience as a Lead Programmer or Technical Lead.


• Proven track record supporting regulatory submissions.

Soft Skills

• Strong communication and stakeholder management abilities.


• Ability to work independently and manage multiple priorities effectively.


• Highly detail\-oriented with a strong commitment to quality and timelines.

Preferred Qualifications

• Experience supporting Translational Medicine or Clinical Pharmacology functions.


• Familiarity with exploratory analyses and early\-phase clinical decision\-making.


• Experience with integrated summaries and pooled PK analyses across studies.


• Exposure to cross\-functional collaboration in drug development environments.

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.

Diese Anzeige stammt von indeed. Originalanzeige ansehen ↗