PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics
Date: Wednesday 6th November 2024 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Our award for statistical excellence in the pharmaceutical industry is made jointly with the Royal Statistician Society (RSS) every year.
The aim of the award is to recognise an outstanding level of influence in the application of an existing statistical practice, or an innovation, that has strengthened the quality and efficiency of investigations in the pharmaceutical industry.
We look for entries that have demonstrated one or more of the following:
Nominees can be based anywhere in the world and do not need to be a member of PSI or the RSS. The award is presented at the annual PSI Conference.
Lisa Hampson was presented with the PSI / RSS Award for Statistical Excellence in the Pharmaceutical Industry. She was nominated for her work on: "Improving the assessment of the probability of success in drug development: A holistic framework encompassing statistical significance, regulatory approval, and market access". Distinguishing it from existing approaches, this framework adopts a broader definition of ‘success’ that bridges statistical significance, clinical relevance, benefit-risk assessments, regulatory alignment, and market access as well as technical development, quality and compliance considerations.
This approach was endorsed by the Novartis Innovation Management Board, chaired by the company’s CEO, in September 2020 and has since then formally been rolled out across the entire portfolio.
In 2022, the PSI/RSS award was presented to a team of biostatisticians and statistical engineers from the healthcare company Roche, in collaboration with the University of Bath. Their winning entry was focused on ‘Standard and reference-based conditional mean imputation (methodology and open-source software)’. The team comprising of Marcel Wolbers, Alessandro Noci, Paul Delmar, Craig Gower-Page, Sean Yiu (of Roche) and Jonathan W. Bartlett (of the University of Bath) were praised by the judges for their innovative approach.
The project addressed the need of trial statisticians in the pharmaceutical industry to fully align their analysis strategy with the targeted estimand and flexible missing data assumptions for clinical trials with continuous longitudinal outcomes. The team present a novel imputation procedure which is fully deterministic (i.e. free of Monte Carlo error) and provides treatment effect estimates consistent with the Bayesian approach as well as reliable frequentist and inference with accurate standard error estimation and type I error control. The companion open-source R package ‘rbmi’ is a flexible toolbox to implement these methods in practice.
Chrissie Fletcher, Chair of PSI, said: ‘The PSI/RSS Statistical Excellence in the Pharmaceutical Industry Award is a significant achievement and recognition of a new statistical innovation created to advance drug development. Well done to the team at Roche who have applied innovative statistical thinking to a common issue in clinical trials relating to missing data and also provided a new R package to implement the methodology.’
Stian Westlake, RSS CEO, added: ‘The team are to be congratulated for this outstanding piece of work which could potentially be a big game-changer for the industry.’
In 2023, Dr Satrajit Roychoudhury of Pfizer won the award for his significant impact in developing, implementing and disseminating efficient statistical methodology in four distinct areas:
For his work on COVID-19 vaccines, he has recognised the urgent need to evaluate and identify a vaccine, but also to enable communication of findings to end users. The end result was one of the first Bayesian Phase III trials that has led to regulatory approval. For many researchers, developing novel methodology ends with acceptance of a manuscript or when the methodology is used in practice. Dr Roychoudhury has gone well beyond that and made it his mission to also educate the wider community on these methods.
Chrissie Fletcher, chair of PSI, said: 'Many congratulations to Satrajit for this significant achievement and well deserved recognition for his statistical excellence in the Pharmaceutical Industry. It is truly outstanding to implement and disseminate efficient statistical methodology in not just one, but four, important and diverse areas. An amazing accomplishment, well done.'
Dr Andrew Garrett, president of the RSS, commenting on the news said: 'Congratulations to Satrajit who should be applauded for the breadth and depth of his contributions. His work on Covid-19 vaccines clearly illustrates impact - notably how Bayesian methods can be used in a confirmatory setting to support regulatory review and approval.'
Date: Wednesday 6th November 2024 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Date: The Second Wednesday of every Month Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Date: Tuesday 19th November 2024 This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.
Dates: Module 1 - Wednesday 20th November Module 2 - Tuesday 26th November Module 3 - Thursday 28th November This interactive and hands on online course, aimed at beginner Bayesians who have little or no experience in Bayesian statistics, is split into 3 modules. Module 1 introduces Bayesian concepts and looks at how Bayes has been used recently in the Pharmaceutical Industry, and participants will undertake their own data collection exercise in order to analyse a simple Bayesian trial. Module 2 takes a look at the concepts of Bayesian statistics and key terminology and provides a chance to analyse some data using a simple Bayesian approach. Module 3 takes a further look at the use of Bayesian statistics in drug development and regulatory requirements and digs deeper into analysis issues.
Date: 20 October 2024 This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
Date: Wednesday 20th November 2024 This is a webinar on the design of studies to assess safety of vaccines administered in pregnancy.
Date: Re-scheduled to Tuesday 26th November 2024 Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
Date: Wednesday 27th November 2024 The 7 Habits of Highly Effective People has had a profound impact on millions of people around the world. The book focuses on cultivating character and refining personality. Its principles are not only transformative for personal growth but also serve as powerful tools for professional development. Over the past few months, members of the PSI Book Club have been exploring these transformative principles through focused discussions and real-world applications. These principles aren’t just theories—they are actionable strategies that can be integrated into your daily life to drive meaningful change. In this upcoming session, we’ll bring these discussions to a broader audience. Together, we’ll explore how to practically apply the 7 Habits in our professional lives, share key insights from our book club sessions, and reflect on how these timeless principles can enhance both our personal and professional journeys.
Date: Tuesday 10th December 2024 This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Date: Thursday 12th December 2024 Chaired by Jenny Devenport, join us to hear Andy Grieve and Zhiwei Zhang discuss their recent work on group sequential designs.
Date: October 2024 - July 2025 An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
An exciting opportunity has arisen for a Senior Medical Statistician & Statistical Programmer to join the UKCRC fully registered Derby Clinical Trials Support Unit (Derby CTSU).
Novartis recently established a Virtual Analytics Network in the UK and we are currently recruiting PhD graduates to join this exciting group!