Principal Statistical Programmer, R Programming

IQVIA LLC; Durham, Northern (NC, KY); Hybrid; USD 98,000 - 273,000; Full time

Job summary

IQVIA LLC is seeking a Principal Statistical Programmer for R development to drive advanced data analysis in clinical trials. You will lead R package development, build R-Shiny dashboards, and generate submission-ready outputs.

Collaboration with statisticians, data managers, and clinicians is essential to meet regulatory standards. The role requires strong expertise in R, R-Shiny, and CDISC standards, with hands-on responsibilities for ADaM, TLFs, SDTM, and data visualization.

Qualifications

• Strong experience in R programming and package/application development for clinical trial data.
• Proven ability to develop and validate R packages for CRO or Pharmaceutical Industry.
• Experience applying R-Shiny for analysis and reporting in clinical studies.

Responsibilities

• Develop, update or validate R packages for clinical trial analysis (SDTM, ADaM, tables, listings, figures).
• Build complex R-Shiny applications (dashboards) for clinical questions and Health Authority needs.
• Generate submission-ready outputs using R-Markdown or similar tools.
• Lead implementation in R and train other team members.
• Write specifications and document applications; collaborate with stakeholders.
• Conduct statistical programming of clinical data using R; verify safety/efficacy outputs.

Skills

R programming

R Shiny

R Markdown

Data visualization

Tools

R packages

SDTM

ADaM

R Shiny

TLFs

R Markdown

Job description

**Principal Statistical Programmer for R Development****Job Overview** 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.**Responsibilities*** Develop, update or validate **R packages** for clinical trial analysis (**SDTM,** **ADaM, tables, figures, listings, submission packages, data review, etc.).*** Building **complex R-Shiny applications** (animations, dashboards) to address clinical questions, Health Authority requirements, and decision-making.* Generate submission ready statistical outputs using R-Markdown or similar tools* **Lead implementation in R** and train other team members.* Write or review specifications and documentation for applications* Collaborate with clinical, statistical and data management stake holders to understand their requirements* Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.* Conduct statistical programming work of clinical data using R.* 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, accuracy and submission readiness of clinical data**Experience and Qualifications*** Strong experience in R programming and package/application development, particularly for clinical trial data including developing and validating R packages from CRO or Pharmaceutical Industry.* **Strong programming skills in R, R Shiny and R Markdown*** **Proven experience in applying R and R-Shiny for the analysis and reporting of clinical trials.*** **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 **clinical trial and drug development** studies is highly desirable though not absolutely require for an exceptional candidate.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.comIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoeIQVIA 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.The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.