Senior Clinical Data Scientist

IQVIA, Inc.; Reading; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the clinical research sector is seeking a Statistical Programmer to develop and validate R packages for clinical trials. The role involves collaborating with peers to ensure data quality and submission readiness, requiring a strong background in R programming and clinical trial processes.

Qualifications

• Minimum 5+ years of experience in R programming for clinical trial data.
• Strong programming skills in R and R Shiny.
• Strong understanding of end-to-end Clinical Trials in Statistical Programming.

Responsibilities

• Develop internal and external R packages for clinical trial analysis.
• Validate R packages and lead implementation in R.
• Create and validate all safety and efficacy study output requirements.

Skills

R programming

R Shiny

Data visualization

Data wrangling

Statistical methodology

Job description

Responsibilities

1. Develop internal and external R packages for clinical trial analysis (ADaM, tables, figures, listings).
2. Validate R packages.
3. Lead implementation in R and train other Biostatistics team members.
4. Create and validate all safety and efficacy study output requirements (e.g., ADaM, TLFs) in accordance with data definitions, specifications, and relevant study documentation (e.g., protocol, SAP, aCRF).
5. Conduct statistical programming work of clinical data using R.
6. Identify problems and develop global tools to increase the efficiency and capacity of the Statistical Programming group.
7. Collaborate with peers and statisticians to ensure the quality and accuracy of clinical data, ensuring submission readiness (e.g., SDTM, ADaM, tables, figures, listings, define.xml).

Experience and Qualifications

• 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 and R Shiny.
• Strong understanding of end-to-end Clinical Trials in Statistical Programming is mandatory.
• 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, with the ability to reproduce statistical analysis using R.
• Strong skills in data visualization and data wrangling using R, including proficiency with R packages for data exploration and visualization.
• Application of statistical methodology and concepts in clinical trial analysis, including experience with R-Shiny apps for data exploration.
• Advanced knowledge of industry standards including CDISC data structures and 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.