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. With 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 today’s episode. Coming from the medical side, he built a business analytics team at Lilly and gave a related keynote presentation at the 2018 PSI conference.
References from the episode:
- PSI webinar “Statistical Engagement with Commercial Activities” on March 12th, 2019
- For the data science SIG: The group is jointly led by Michelle and Steve Jones (Covance). If you wish to join, please contact Michelle at michelle.jones-modeling@covance.com.
- Slides for the Keynote by Steve at the PSI conference 2018 in Amsterdam.
- Link to the video on demand area at the PSI homepage.
- Article about drug waste in oncology by Lisa Hess et al.
Featured courses
Click on the button to see our Teachble Inc. cources.
Stephen Ruberg
Distinguished Statistical Scientist at 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, at Advanced Analytics, Eli Lilly & Company. He is also an 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 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.
Join The Effective Statistician LinkedIn group
This group was set up to help each other to become more effective statisticians. We’ll run challenges in this group, e.g. around writing abstracts for conferences or other projects. I’ll also post into this group further content.
I want to help the community of statisticians, data scientists, programmers and other quantitative scientists to be more influential, innovative, and effective. I believe that as a community we can help our research, our regulatory and payer systems, and ultimately physicians and patients take better decisions based on better evidence.
I work to achieve a future in which everyone can access the right evidence in the right format at the right time to make sound decisions.
When my kids are sick, I want to have good evidence to discuss with the physician about the different therapy choices.
When my mother is sick, I want her to understand the evidence and being able to understand it.
When I get sick, I want to find evidence that I can trust and that helps me to have meaningful discussions with my healthcare professionals.
I want to live in a world, where the media reports correctly about medical evidence and in which society distinguishes between fake evidence and real evidence.
Let’s work together to achieve this.
