Why you should listen

If you work in statistics, data science, statistical programming, or clinical development, this episode will give you a practical look at how the industry is moving toward more modern and collaborative approaches.

You’ll learn:

• How the R Consortium is helping pharmaceutical companies work together and collaborate with the FDA.
• What the R Consortium’s regulatory submission pilots can teach you about using R in real-world submissions.
• How open-source collaboration can influence regulatory guidance and industry practices.
• How tools like R, Shiny, containers, and WebAssembly could make regulatory submissions more interactive and reproducible.
• How the community is beginning to explore generative AI for clinical trials and statistical programming.
• Why benchmark datasets, challenging test cases, and quality control will be critical for using AI responsibly.
• How you can explore the R Consortium’s public resources and get involved in its work.
• Whether you’re already using R or simply want to understand where statistical programming and regulatory submissions are heading, this conversation with Ning Leng will give you valuable insights into the future of our field.

Episode highlights with timestamps

• 01:30 — Meet Ning Leng and her journey into R
  Ning introduces her background in statistics and computational genomics and explains how she became involved in R adoption, cloud migration, Git, and Shiny at Roche Genentech.
• 03:57 — Why R wasn't being used for regulatory submissions
  Ning explains the misconception that the FDA did not accept R and identifies the real challenge: the industry lacked practical examples showing how to submit R-based materials.
• 05:46 — What is the R Consortium?
  We discuss the R Consortium's role as a nonprofit organization that promotes good practices and the use of R across industries.
• 06:16 — How the R Consortium collaborates with the FDA
  Ning explains the submission working group, validation hub, and how the Consortium provides a platform for collaboration between pharmaceutical companies and the FDA.
• 08:13 — R Consortium FDA submission pilots
  Ning walks through the different pilots, from submitting TLGs to incorporating Shiny, ADaM code, containers, WebAssembly, and alternative data formats.
• 10:29 — How companies are using the pilot submissions
  We explore how pharmaceutical companies use the public R Consortium pilots as practical templates when preparing their own R-based regulatory submissions.
• 11:24 — How collaboration influenced FDA guidance
  Ning explains how lessons from the pilots helped clarify FDA guidance around file formats, including .r and .zip files.
• 12:17 — Moving beyond PDF-based electronic submissions
  We discuss the opportunity to use interactive graphics, HTML, Shiny, and other modern technologies to make electronic regulatory submissions more useful and traceable.
• 14:14 — Generative AI enters the picture
  Ning explains how the R Consortium is beginning to explore generative AI for clinical trial reporting, trial design, and statistical programming.
• 15:12 — Building AI skills and benchmark test cases
  We discuss open-source AI skills, benchmark datasets, and the importance of testing AI against difficult and unusual corner cases.
• 16:28 — How you can get involved with the R Consortium
  Ning shares practical ways to explore the community, including its public working-group materials, meeting minutes, recordings, and Slack channel.

Links and Resources:

🔗 R Consortium: Learn more about the R Consortium and its work to promote the use of R and good practices across industries: https://r-consortium.org/

🔗 R Consortium R Submissions Working Group: Explore the working group's projects, meeting materials, submission pilots, and opportunities to get involved: https://rconsortium.github.io/submissions-wg/

🔗 R Submissions Working Group — Pilot Projects: Learn about the different FDA submission pilots and how the community is exploring R for regulatory submissions: https://rconsortium.github.io/submissions-wg/pilot_background.html

🔗 R Consortium 2026 Plans and 2025 Success: Read about the latest work from the R Submissions Working Group, including the development of Pilots 6 and 7: https://r-consortium.org/posts/submissions-wg-2026/

🔗 Pilot 4 — WebAssembly and Containers: Learn how the R Consortium explored submitting a Shiny application using WebAssembly and containers for FDA review: https://r-consortium.org/posts/using-r-to-submit-research-to-the-fda-pilot-4-successfully-submitted/

🔗 R Consortium Working Groups: Browse the R Consortium's different working groups and projects: https://r-consortium.org/all-projects/isc-working-groups.html

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🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.

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