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PK/PD Statistical Programmer(m/w/x)
Programming and validating NONMEM-ready datasets for clinical trial data in drug development. 6+ years industry experience in clinical data analysis and expert R proficiency required. Work in a global clinical research environment.
Anforderungen
- Bachelor's or Master's degree in health, science, IT, mathematics, or related field
- Minimum 6 years industry experience in clinical data analysis, statistical programming, or pharmacometrics support
- Expert-level proficiency in R
- Hands-on experience creating NONMEM datasets
- Strong understanding of SDTM, ADaM, and controlled terminology
- Applied knowledge of PK/PD principles and clinical trial concepts
- High attention to detail, strong analytical, documentation, and communication skills
- Ability to work independently and collaboratively
- Experience building/enhancing NONMEM dataset workflows
- Experience with R package testing, validation frameworks, or reproducible programming
- Familiarity with pharmacometrics workflows
Aufgaben
- Program, validate, and deliver NONMEM-ready PK/PD datasets.
- Create high-quality PK/PD datasets for pre-lock and post-lock clinical data.
- Execute complex programming tasks independently.
- Critically review data.
- Identify data inconsistencies and gaps.
- Propose solutions for dataset quality and programming efficiency.
- Perform quality control on internal and external NONMEM datasets.
- Assist in preparing deliverables for regulatory submissions.
- Perform QC on customized R packages.
- Enhance or build automated test suites.
- Collaborate with cross-functional teams to resolve data issues.
- Ensure alignment with cross-functional teams.
- Adhere to SOPs, working instructions, and regulatory standards.
- Maintain inspection readiness.
- Drive PM standardization for dataset creation and QC.
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- R
- NONMEM
- SDTM
- ADaM
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- IQVIAVollzeitmit HomeofficeSeniorFrankfurt am Main
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PK/PD Statistical Programmer(m/w/x)
Programming and validating NONMEM-ready datasets for clinical trial data in drug development. 6+ years industry experience in clinical data analysis and expert R proficiency required. Work in a global clinical research environment.
Anforderungen
- Bachelor's or Master's degree in health, science, IT, mathematics, or related field
- Minimum 6 years industry experience in clinical data analysis, statistical programming, or pharmacometrics support
- Expert-level proficiency in R
- Hands-on experience creating NONMEM datasets
- Strong understanding of SDTM, ADaM, and controlled terminology
- Applied knowledge of PK/PD principles and clinical trial concepts
- High attention to detail, strong analytical, documentation, and communication skills
- Ability to work independently and collaboratively
- Experience building/enhancing NONMEM dataset workflows
- Experience with R package testing, validation frameworks, or reproducible programming
- Familiarity with pharmacometrics workflows
Aufgaben
- Program, validate, and deliver NONMEM-ready PK/PD datasets.
- Create high-quality PK/PD datasets for pre-lock and post-lock clinical data.
- Execute complex programming tasks independently.
- Critically review data.
- Identify data inconsistencies and gaps.
- Propose solutions for dataset quality and programming efficiency.
- Perform quality control on internal and external NONMEM datasets.
- Assist in preparing deliverables for regulatory submissions.
- Perform QC on customized R packages.
- Enhance or build automated test suites.
- Collaborate with cross-functional teams to resolve data issues.
- Ensure alignment with cross-functional teams.
- Adhere to SOPs, working instructions, and regulatory standards.
- Maintain inspection readiness.
- Drive PM standardization for dataset creation and QC.
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- R
- NONMEM
- SDTM
- ADaM
Über das Unternehmen
IQVIA
Branche
Pharmaceuticals
Beschreibung
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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