Data science or just statistics on non-medical data? A new horizon for statisticians

Interview with Stephen Ruberg

There’s a long tradition of statisticians working on clinical studies as well as other related data, e.g. pre-clinical data and observational data. In the advent of big data and data sciences, there’s a considerable pull from the business side of pharma to employ statistical approaches as well.

This leads to questions like:

  • Is this an area for medical statisticians to enter?
  • Are medical statisticians equipped to enter this field?
  • What should medical statisticians focus on, to be prepared for the upcoming changes?

Stephen Ruberg answers these and related questions in todays episode. Coming from the medical side, he built such a business analytics team at Lilly and gave a related keynote presentation at the 2018 PSI conference.

References from the episode:

About Stephen Ruberg

Analytix Thinking LLC

Stephen J. Ruberg, PhD is President of Analytix Thinking, LLC, a consulting company focused on strategic and technical consulting for drug development as well as teaching statistical concepts to non-statisticians. Previously, Dr. Ruberg was a Distinguished Research Fellow and Scientific Leader, Advanced Analytics, Eli Lilly & Company. He is also Adjunct Professor of Statistics at Purdue University.

In the pharmaceutical industry since 1981, he has been an industry leader in the development and application of statistical methods in drug development as well as advances in data management and eClinical technology.

He has published widely in statistical, scientific, and industry trade journals and is a frequent speaker at statistical and scientific conferences. Among other awards and recognitions, in 1994, he was elected a Fellow of the American Statistical Association (ASA) and in 2012 received the Career Achievement Award from Quantitative Scientists in the Pharmaceutical Industry (QSPI).


Dr. Ruberg was Deputy Chair for the ICH Expert Working Group that published the ICH-E9 document Statistical Principles for Clinical Trials. He received the FDA Commissioners Special Citation for his work on electronic NDAs. He was on the Executive Committee of the ASA Biopharmaceutical Section and was Chair of the PhRMA Biostatistics and Data Management Steering Committee. He was the first Chairman of the Board of Directors for the Clinical Data Interchange Standards Consortium (CDISC) and was actively involved with CDISC for its first seven years. In the past, he served as Chair of the Board of Trustees of the Mathematical Biosciences Institute at The Ohio State University, and was appointed by the Secretary of Health and Human Services (HHS) to the board of directors for the National eHealth Collaborative, which was working to create the Nationwide Health Information Network. 


Dr. Ruberg received a BA in Mathematics from Thomas More College, an MS in Statistics from Miami University in Ohio, and a PhD in Biostatistics from the University of Cincinnati.

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