IQVIA
Principal Statistical Programmer - FSP(m/w/x)
Vollzeitnur vor OrtSenior
Frankfurt am Main
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
QUQUK IQVIA Ltd.
Principal Statistical Programmer (PK/PD)(m/w/x)
Frankfurt am Main
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- CDISC standards
- SDTM
- ADaM
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens QUK IQVIA Ltd. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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QUQUK IQVIA Ltd.
Principal Statistical Programmer (PK/PD)(m/w/x)
Frankfurt am Main
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- CDISC standards
- SDTM
- ADaM
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens QUK IQVIA Ltd. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
QUK IQVIA Ltd.
Branche
Healthcare
Beschreibung
IQVIA provides clinical research, commercial insights, and healthcare intelligence to life sciences and healthcare industries, accelerating innovative medical treatments.
Noch nicht perfekt?
- IQVIA
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