Senior Clinical Data Scientist
IQVIA
Dato: for 2 uger siden
By: København, Region Hovedstaden
Kontrakttype: Fuld tid
Fjernarbejde

Responsibilities
- Develop internal and external R packages for clinical trial analysis (ADaM, tables, figures, listings).
- Validate R packages.
- Lead implementation in R and train other Biostatistics team members.
- Create and/or validate all safety and efficacy study output requirements (e.g. ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF)
- Conduct statistical programming work of clinical data using R.
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
- Collaborates with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
- Minimum 5+ years of experience in R programming for clinical trial data including developing and validating R packages from CRO or Pharmaceutical Industry
- Strong programming skills in R/R Shiny
- Strong understanding of end to end Clinical Trials in Statistical Programming is a mandatory for this role.
- Exposure to Late Phase & Real-World Evidence (RWE) studies is highly desirable.
- Proven experience in applying R and R-Shiny for the analysis and reporting of clinical trials. Ability to reproduce statistical analysis using R.
- Strong skills in data visualization and data wrangling using R. Proficiency in using R packages for data exploration and visualization.
- Application of statistical methodology and concepts in clinical trial analysis. Experience with R-Shiny apps for data exploration.
- Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs.
- In-depth understanding of the phases of clinical trials and the drug development process.
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