IQVIA
Principal Statistical Programmer - FSP(m/w/x)
Full-timeOn-siteSenior
Frankfurt am Main
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QUQUK IQVIA Ltd.
Principal Statistical Programmer (PK/PD)(m/w/x)
Frankfurt am Main
Full-timeOn-siteSenior
Nejo AI Summary
Developing CDISC-compliant PK/PD and safety ADaM datasets for clinical pharmacology. Expert SAS programming and hands-on CDISC standards experience required. Collaboration with biostatistics and translational medicine teams.
Requirements
- Expert-level SAS programming proficiency
- Hands-on CDISC standards experience (SDTM, ADaM)
- TLF generation experience
- Safety datasets development experience
- PK and PK/PD ADaM datasets development experience
- PopPK / PK/PD / Exposure–Response workflows support experience
- Solid understanding of early-phase clinical trial designs
- Phase I / First-in-Human (FIH) studies knowledge
- Crossover studies knowledge
- Exposure–response analysis knowledge
- PK parameter pooling knowledge
- Statistical programming experience in pharma/CRO
- Lead Programmer or Technical Lead experience
- Regulatory submissions support track record
- Strong communication abilities
- Stakeholder management abilities
- Independent work ability
- Effective multiple priorities management
- Detail-oriented with quality commitment
- Timelines commitment
- Translational Medicine support experience
- Clinical Pharmacology functions support experience
- Familiarity with exploratory analyses
- Familiarity with early-phase clinical decision-making
- Integrated summaries experience
- Pooled PK analyses experience across studies
- Cross-functional collaboration exposure in drug development
Tasks
- Lead development and validation of CDISC-compliant datasets
- Design and implement PK, PK/PD, and safety ADaM datasets
- Ensure compliance with industry standards and regulatory requirements
- Support PopPK, PK/PD, and ER analyses by developing datasets
- Collaborate with Clinical Pharmacology, Biostatistics, and Translational Medicine teams
- Support early-phase decision-making
- Provide programming leadership for Phase I and First-in-Human trials
- Contribute to regulatory submissions
- Ensure datasets and outputs meet global health authority standards
- Develop and maintain standard programming practices
- Create macros and QC processes to enhance efficiency and quality
- Mentor junior programmers
- Guide project delivery
- Adhere to timelines, quality standards, and documentation requirements
- Support integrated and pooled PK datasets across studies
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- CDISC standards
- SDTM
- ADaM
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of QUK IQVIA Ltd. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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QUQUK IQVIA Ltd.
Principal Statistical Programmer (PK/PD)(m/w/x)
Frankfurt am Main
Full-timeOn-siteSenior
Nejo AI Summary
Developing CDISC-compliant PK/PD and safety ADaM datasets for clinical pharmacology. Expert SAS programming and hands-on CDISC standards experience required. Collaboration with biostatistics and translational medicine teams.
Requirements
- Expert-level SAS programming proficiency
- Hands-on CDISC standards experience (SDTM, ADaM)
- TLF generation experience
- Safety datasets development experience
- PK and PK/PD ADaM datasets development experience
- PopPK / PK/PD / Exposure–Response workflows support experience
- Solid understanding of early-phase clinical trial designs
- Phase I / First-in-Human (FIH) studies knowledge
- Crossover studies knowledge
- Exposure–response analysis knowledge
- PK parameter pooling knowledge
- Statistical programming experience in pharma/CRO
- Lead Programmer or Technical Lead experience
- Regulatory submissions support track record
- Strong communication abilities
- Stakeholder management abilities
- Independent work ability
- Effective multiple priorities management
- Detail-oriented with quality commitment
- Timelines commitment
- Translational Medicine support experience
- Clinical Pharmacology functions support experience
- Familiarity with exploratory analyses
- Familiarity with early-phase clinical decision-making
- Integrated summaries experience
- Pooled PK analyses experience across studies
- Cross-functional collaboration exposure in drug development
Tasks
- Lead development and validation of CDISC-compliant datasets
- Design and implement PK, PK/PD, and safety ADaM datasets
- Ensure compliance with industry standards and regulatory requirements
- Support PopPK, PK/PD, and ER analyses by developing datasets
- Collaborate with Clinical Pharmacology, Biostatistics, and Translational Medicine teams
- Support early-phase decision-making
- Provide programming leadership for Phase I and First-in-Human trials
- Contribute to regulatory submissions
- Ensure datasets and outputs meet global health authority standards
- Develop and maintain standard programming practices
- Create macros and QC processes to enhance efficiency and quality
- Mentor junior programmers
- Guide project delivery
- Adhere to timelines, quality standards, and documentation requirements
- Support integrated and pooled PK datasets across studies
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- CDISC standards
- SDTM
- ADaM
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of QUK IQVIA Ltd. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
QUK IQVIA Ltd.
Industry
Healthcare
Description
IQVIA provides clinical research, commercial insights, and healthcare intelligence to life sciences and healthcare industries, accelerating innovative medical treatments.
Not a perfect match?
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Full-timeOn-siteSeniorFrankfurt am Main - Sanofi
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