Benefit-Risk SIG

The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.

The main aims of the SIG are:

  • To understand how best to apply Benefit-Risk methodologies across the Pharmaceutical Industry
  • To discuss and make recommendations on key methodological issues
  • To share examples of how Benefit-Risk has been used within pharmaceutical companies
  • To share external information including new developments around Benefit-Risk

Currently the SIG has subgroups working on:

  • Literature review
  • Benefit-Risk in the HTA setting (together with the HTA SIG)
  • Bayesian applications in Benefit-Risk
  • Preference elicitation and  Benefit-Risk

We also develop relevant training in the area of structured  Benefit-Risk as needed.

If you have an interest in being involved in this SIG, or have an interesting case study or experience of carrying out a structured Benefit-Risk assessment to share, please contact Maria Costa (email: maria_j.costa@novartis.com)

Our BLOG can be found under www.benefit-risk-assessment.com. It is a great source of information for all things Benefit-Risk related: upcoming conferences, journal publications, training, and much more.

Upcoming Events

Introduction To Industry Training Course 2020

The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 sessions in the UK. The start of the 2020-2021 course will be delayed until face-to-face meetings with up to 30 people are permitted and companies are allowing travel again.

PSI Webinar: Patient preference studies

In this webinar you will hear an introduction to what a patient preference study is as well as an overview of where this type of study can inform regulatory decision making. This will be followed by 2 examples looking at potential approaches to eliciting patient preference.

PSI Vaccine SIG Webinar: Statistical Topics on COVID-19 Therapeutic and Vaccine Clinical Trials

We are delighted to be joined by Frank Harrell who will present 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Therapeutic Trials'; and also by Dean Follmann, who will present on 'Statistical Aspects of COVID-19 Vaccine Trials'. Join us for this insightful and highly topical webinar.

Joint PSI, EFSPI & ASA BIOP Webinar: Estimands

PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.

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