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R Training Strategies at Janssen

R Training Strategies at Janssen

Summary: As the Pharmaceutical sector boosts its interactions with regulatory agencies using R programming as one key instrument for drug development submissions, we face a dilemma that several members of statistics and statistical programming teams are not currently advanced R programmers. At Janssen, we aim to improve the literacy in R programming and achieve nearly 100% adoption by these teams. To achieve this goal, we are leveraging all types of training formats, from online training to in-house instructor-led seminars, to one-on-one mentoring as well as internal crowd-led hands-on workshops where statisticians/programmers are “thought” to solve on-the-job real problems ranging from visualization to automated reports. In this presentation we will discuss our experience implementing these strategies, challenges we faced, share lessons learned, mistakes and successes. We will also discuss topics on continued support and change management. A panel discussion with members from other pharmaceutical companies will close the event.

Paulo R. Bargo, Daniel Hofstaedter and Gayathri Kolandaivelu at Janssen Pharmaceuticals R&D


  • Intro – 5 mins
  • Presentation – 45 mins
  • Q&A – 10 mins
  • Panel Discussion – 30 mins
Paulo R. Bargo, Ph.D., Head of R&D Data and Advanced Analytics, Ethicon, part of the Johnson & Johnson Family of Companies
Dan Hofstaedter is a statistical programmer within the Janssen Clinical & Statistical Programming group. 
Gayathri Kolandaivelu has over 13 years of experience in the pharmaceutical industry.

Paulo Bargo is currently the head of Data and Advanced Analytics for Ethicon R&D, developing strategies to enable Ethicon’s digital transformation and promoting use of open-source solutions as well as developing training initiatives to improve data literacy. He was head of Scientific Computing for Statistics & Decision Sciences at Janssen Pharmaceuticals R&D for 5 years, developing cloud computing strategies to enable data science projects in clinical and non-clinical space. Prior to joining the pharmaceutical sector, he spent 13 years in the consumer and personal industry with tenures at Johnson & Johnson Consumer Companies and L’Oreal USA. He is a member of the R Validation Hub executive committee and the R/Pharma executive committee.

Paulo has a BS in Electrical Engineering (EE), MS in Biomedical Engineering and a PhD in EE. During his scientific career he published 13 peer-reviewed articles, 1 book chapter and authored/presented 40+ abstracts in scientific conferences.

Dan Hofstaedter: Over the course of his twenty years at Janssen, he has led the programming efforts for numerous regulatory submissions within the Immunology therapeutic area and was the primary author of the Janssen SAS Reporting Macro suite.  More recently, Dan has supported the adoption of R within Janssen, co-leading the R Training initiative.        

Dan has BS Degrees in Mathematics and Business Administration from Delaware Valley University and an MS Degree in Applied Statistics from Villanova University.  Prior to entering the field of statistical programming, Dan was a high school mathematics teacher.

Gayathri Kolandaivelu is currently an associate director supporting sourcing and process group in Business operations in Clinical and statistical programming group at Janssen Pharmaceutical company (JnJ), Springhouse, PA.  She was a pediatric portfolio lead in immunology and has experience in Early Development, Late Development, and Regulatory Submission. Worked as a Clinical programmer, Programming Lead, Portfolio Lead in Janssen and ICON.  She is a Change management lead (Prosi certified) and a communication lead for Clinical and statistical programming in Janssen. She is a Design thinking expert has conducted many DT workshops for PHUSE US connects and CSS.

She has a Master’s in Bioengineering from UT southwestern medical center/UTA, Dallas, Texas and currently pursuing MBA from Drexel Lebow, Philadelphia, Pennsylvania.

The R Adoption Series

This is a new series of webinars focused on the adoption of R.  Each session will include a case study and often include panels or discussions to enable those starting their journey to ask questions.

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