Katrina Gore and Nicky Best (joint winners, 2015, Pfizer and GSK respectively). Katrina Gore for her work on the Assay Capability Tool (ACT), designed to guide the development of drug discovery assays. Nicky Best for her work implementing a process that has turned beliefs about the chances of success into formal prior distributions.

Richard Nixon of Novartis was presented with the award in 2016 for “Enhancing decision-making in drug development using quantitative approaches’.

The 2017 award was presented to Michael O'Kelly for his work 'Promoting analytical solutions and best practices for handling missing data in pharmaceutical industry'.  The judges felt that in this respect, he has made a major contribution to enhancing the practical application of modelling and simulation methodology and tools for analysing data with missing values. 

The 2018 award was jointly presented to Dr. Mouna Akacha (Novartis) for “Enhancing drug development using clinically interpretable treatment effect measures (‘estimands‘) that allow for efficient statistical analyses” and Dr. Simon Bate for “Improving the quality and reliability of animal research through the use of InVivoStat: a statistical software package for animal researchers”. 

The 2019 award was jointly presented to Mike Smith (Pfizer) for his work on ‘Excellence in research around population modelling in drug development’ and its ‘pioneering practical Bayesian methods with drug development in the context of optimising decision making within trials and modelling dose response with pharmacokinetic/pharmacodynamic modelling’ and Graeme Archer and Jacquie Christie (GSK) for their work on ‘Quantitative Decision-Making for clinical development’, which was deemed to be ‘at the cutting edge of revolutionising data driven decision making within the industry’. 

The 2020 award was presented to Dr. Sandeep M Menon, Senior Vice President and Head of Early Clinical Development at Pfizer, for “Influential Quantitative Leadership in several domains in Early Clinical Development - creating a culture of quantitative decision making within a major pharmaceutical company.” The judging panel found Dr Menon’s work to be an impressive demonstration of the value of biostatistics as well as an effective promotion of statistical thinking within a large organisation. Tim Rolfe, chair of the PSI award committee said “Dr Menon is a well deserving winner of this year's award. His impact as an innovative statistical leader shone through-out the successful nomination.”

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: 

• Bayesian design for COVID-19 vaccine trial
• Use of external control data
• Implementation of model-based approach in Phase I oncology studies
• Statistical approaches for non-proportional hazard

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.'

The 2024 Statistical Excellence in the Pharmaceutical Industry Award is awarded to the GSK Biostatistics team lead by Nicky Best for their entry ‘Successful Use of Bayesian Dynamic Borrowing Methods in Regulatory Settings’.

The GSK Biostatistics team has successfully used Bayesian Dynamic Borrowing (BDB) in a commercial setting, which allows for the re-use of external data, synthesising new and existing data to increase efficiency whilst maintaining rigorous standards for regulatory decision making.

The judging panel was impressed by the culmination of years of work invested in this project – starting with the development and publication of innovative methodology, followed by diligent efforts to communicate this methodology to regulators and stakeholders. The acceptance of Bayesian approaches by regulators is a big step forward, widely acknowledged within the industry and beyond.

The award presentation took place at the PSI annual conference in Amsterdam, where Nicky Best and Andrea Callegaro collected the award on behalf of the Biostatistics team.

RSS CEO Sarah Cumbers said, ‘A well-deserved congratulations go to the team at GSK. The inclusion of Bayesian Dynamic Borrowing in recent examples of regulatory decisions represents a paradigm shift that is a huge step forward in the pharmaceutical industry’.

David Wright, chair of PSI said, ‘Many congratulations to Nicky Best, Andrea Callegaro, Brigitte Cheuvart, Cui Xiong, Dawn Edwards and Jodie Crawford for their work on commercialization of Bayesian Dynamic Borrowing. It is a significant achievement and well-deserved recognition for their statistical excellence in the pharmaceutical industry.’