Join a sponsor-dedicated team and contribute to the advancement of in-house study activities over time. As the R Programming Lead, you will provide technical expertise to the Statistical Programming team, ensuring the delivery of high-quality solutions that meet both internal and external requirements.
Responsibilities
• Develop internal and external R packages for clinical trial analysis (ADaM, tables, figures, listings).
• Validate R packages.
• Building complex R-Shiny applications (animations, dashboards) to address clinical questions, EU JCA requirements, and decision-making.
• Lead implementation in R and train other Biostatistics team members.
• 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.
• 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)
• 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).
Experience and Qualifications
• Strong 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
• 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.
• Ability to conduct statistical programming of clinical data using R, and create/validate safety and efficacy outputs (ADaM, TLFs) aligned with study documentation (protocol, SAP, aCRF).
• Exposure to Late Phase , Real-World Evidence (RWE) & Global Medical Affairs studies is highly desirable.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
