Principal Statistical Programmer, R Programming

IQVIA • Durham, NC

1d

About The Position

The Statistical Programmer is a key contributor to the research team, playing a crucial role in analyzing and interpreting complex data sets. They are responsible for developing and implementing statistical methodologies that will enhance our study outcomes. Reporting to the team manager, the programmer must ensure data integrity and accuracy in every phase of the project. With proficiency in various programming languages and statistical tools, they collaborate closely with team members to streamline data processes and deliver insights that drive decision-making.

Requirements

• 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).

Nice To Haves

• Exposure to Late Phase , Real-World Evidence (RWE) & Global Medical Affairs studies is highly desirable.

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, Health Authority 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed