Meet the PSI Board of Directors

David Wright

David Wright, PSI Chair

After studying for a MSc in Medical Statistics at the University of Leicester and a PhD in Statistics at QMW, University of London, David did a Post Doc at the University of Warwick on risk scores and became a Lecturer in Medical Statistics at UCL working on risk factors associated with neonatal arterial switch operations.

David has more than 20 years’ experience in the pharmaceutical industry. The first 16 years as a statistical assessor at the MHRA where he went on to Chair the Biostatistics Working Party at the EMA from 2011-2016. Since 2016 David has worked for AstraZeneca as Head of Statistical Innovation leading a team working on methodological issues associated with the design and analysis of clinical trials.

David co-authored the revision to the CHMP guideline on missing data and is a member of the EFPSI/EFPIA Estimands Implementation Working Group and a member of the EFSPI Scientific Committee.



Chrissie Fletcher

Chrissie Fletcher, Vice Chair and Secretary

Chrissie is passionate about her profession as a statistician and the significant value statistics has in development and commercialisation of new medicines in the Pharmaceutical Industry.

Chrissie is the VP of Development Biostatistics at GSK and previously held various roles in the Biostatistics at Amgen and SmithKline Beecham.

For nearly 30 years, she has supported a wide range of associations where she is widely recognised for her expertise and leadership in shaping her profession and broader industry initiatives. PSI was the first association Chrissie joined back in 1991 and she has supported ITIT/Training, Scientific, Treasurer and Regulatory activities. Chrissie has also supported a variety of SIG’s, including the HTA SIG, for the last ten years. She was awarded an Honorary Membership in 2019 for her services to PSI.


 

Kimberley Hacquoil

Kimberley Hacquoil, Careers Director

Kim has over 15 years’ of experience in the pharmaceutical industry working as a statistician. She has worked in a number of different therapeutic areas, mainly in early development. She has championed new approaches to decision making in clinical development through initiatives developing and promoting innovative/novel designs, and statistical methodology including futility and predictive inference, prior elicitation, assurance and quantitative decision making. She has also worked in strategy and portfolio management as a Statistics & Mathematical Modelling Director. Kim has recently taken on a new role as the Chief Data Scientific Officer at Exploristics.

Kim has been an active member of PSI for many years and has previously been part of the New Starters SIG and the Careers and Academic Liaison Committee (CALC).

Kim received her BSc in Mathematics from Bath University and MPhil in Statistical Sciences from Cambridge University.

 


Aiden Flynn

Aiden Flynn, Commercial Director

Dr Aiden Flynn has over 25 years’ experience in drug discovery and clinical development, with ten years at GlaxoSmithKline as a Director of Statistical Support for Biomarker Studies across R&D.  There he was responsible for developing and implementing the company’s Pharmacogenetics strategy enabling the use of genetics data in clinical studies.  This involved the development and integration of new analysis tools and methods, data standards, processes and training.  Aiden has in-depth experience in developing computer simulation tools for the design and analysis of complex trials and has worked closely with the FDA and EMA to develop tools and guidelines that support the use of biomarkers in clinical studies. 

In 2009, he set up Exploristics, a privately owned, commercial company providing statistical products and services in support of clinical trial design and analysis.  Since it was founded, Aiden has overseen the consistent growth in the company.

 

 

 

 

Alun Bedding

Alun Bedding, Communications Committee and External Affairs (and EFSPI) Chair 

Alun is the current Global Head of Methods, Collaboration and Outreach in the Statistics department at Roche. He has worked in the pharmaceutical industry for over 30 years and been a member of PSI for all that time having also served on the Board of Directors twice previously, first as Secretary and latterly as Treasurer. Alun also worked as editor on the SPIN newsletter in the past. Alun is currently involved with the PSI mentor program and has been the internal auditor for PSI. 

Alun is a member of the DIA Innovative Design Working Group and Bayesian Methods Working Group and also a statistical member of the UK Medical Research Council Experimental Medicine funding panel and the Great Ormond Street Hospital funding panel. 

 

Kate Taylor

Kate Taylor, Events Director

Kate has been an active member of PSI for 10 years. Kate sat on CALC from 2013-2016, helping the group to organise many successful events and promoting the industry to school age and university students.

Since 2016, Kate has been a part of the Scientific Committee, acting as vice-chair for the 2018, 2021 and 2022 conferences and Chair for the 2019 and 2020 conferences, which were held in London and online. She has loved playing a part in PSI’s largest annual event each year.

As part of being the Conference Chair, Kate has also sat on the PSI Board before, from 2018-2020 and thoroughly enjoyed the experience. If elected again, she hopes to continue working to provide a comprehensive, exciting and coordinated set of events for the PSI community alongside other committee members, as well as playing an active role in all areas of PSI that the board discusses.


Kate Tsirtsonis, Membership Chair

Kate has over 15 years of experience in the Pharmaceutical Industry, working as a Statistician and a Statistical Programmer across early and late stage therapeutic areas, performing varying roles. She is currently European Statistical Lead for General Medicine within Amgen.

Before joining the Pharmaceutical Industry, Kate obtained a Bsc in Maths with Actuarial Studies and an Msc in Medical Statistics from the University of Southampton.

Kate has been involved in PSI for many years but is now enjoying taking an active part in the PSI Membership Committee, focusing on widening out the PSI community.

Outside of work, Kate is a keen, yet distinctly average, runner. She also has two active young boys, so family life keeps her very busy.

 


Adam

Adam Crisp, Special Interest Group (SIG) Director

Adam is Head of Infectious Disease Statistics at GSK with 25 years’ industry experience across all phases of drug development and multiple therapeutic areas. Educated and based in the UK, Adam has extensive experience in the design and conduct of cardiovascular outcomes trials and in working with the associated external groups. Adam is a member of GSK’s “Global Safety Board” and is a GSK Senior Fellow. Adam has previously served on the PSI Scientific Committee and joined the Board in December 2019.

Adam has a range of statistical interests, with recent publications on topics such as use of assurance to support decision making in drug development, the changing landscape of Data Monitoring Committees and a wide-ranging overview of blinding in clinical trials; recent external presentations have included contributions as a keynote speaker at the Indian Association for Statisticians in Clinical Trials 2018 conference (on Go/No-go criteria), as panellist at the 2017 ISBS Conference session “Data Monitoring Committees – Scope, Expectations and Challenges” and as speaker at the 2016 ASA Biopharmaceutical Workshop on “Futility assessments in late-phase drug development: a novel two-stage outcomes trial in Acute Coronary Syndrome”.

Adam received his PhD in Statistics from University College London and has a Diploma in Mathematical Statistics from Cambridge University.

 

Markus Elze

Markus Elze, Contracts and Finance Director

Markus Elze is Biostatistician at Roche with a focus on late stage Oncology, based in Basel. He works mainly in cancer immunotherapy, including some early phase and paediatric trials, as well as in biomarker work. His interests include computational tools (especially R for the generation of valid outputs), decision-making in early phase settings and paediatric studies.

Markus has been an active member of PSI for several years, including presentations at the conference and membership in the PSI AIMS SIG. He is an active member of RSS and was also a Young Statisticians Section Committee member in 2016.

Markus obtained his PhD in Statistics from the University of Warwick with a thesis on joint modelling of time-to-event and longitudinal processes and did a PostDoc at The London School of Tropical Medicine.  

Markus’ hobbies include technology, space, travelling and food.

 

Upcoming Events

PSI VisSIG Wonderful Wednesday Webinar Series (2023)

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.

PSI Webinar: Application of Bayesian Methods in Confirmatory Trials

This webinar consists of three presentations providing examples of where Bayesian methods have been used within confirmatory settings.

PSI Launch & Lifecycle SIG Webinar: Do you want to stay single? Considerations on single arm trials in the post-regulatory space

We will present the most frequently asked questions in the post-marketing space, the reasons why SATs are not able to address these questions, and how statisticians might reasonably influence decision makers to consider alternatives.

PSI Training Course: Missing Data

This course will introduce participants to the key concepts and methods relevant for analysing clinical trials when some data are missing.

PSI Scientific Meeting: Patient-focused drug development

The meeting will consider the importance of patient-centric input into regulatory and HTA decision-making discussing the latest developments in the field and presenting industry examples.

PSI Book Club

The next book we are reading is "The 7 Habits of Highly Effective People" by Stephen R. Covey. This is a classic in the personal development genre.

PSI Pre-Clinical SIG Webinar: Adjusting Experimental & Statistical Approaches throughout Preclinical development pathways

PD Dr. Tölch will present a framework to foster efficient evidence generation in preclinical experiments and will illustrate the proposed approach using examples from various projects. This will be followed by Q&A.

PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies

Our speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.

PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

A careers talk about medical statistics and how it plays a crucial role in developing new medicines

PSI Journal Club: Bayesian Approaches in Efficacy and Safety

Please join us to hear Kristian Brock and Ying Yuan present their recent work for our next Journal Club webinar, as sponsored by Wiley.

PSI Training Course: Sample Sizing for Clinical Trials

This course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.

PSI Biomarkers SIG Webinar: A promising adaptive biomarker-based design strategy for early phase and machine learning as an enabler of precision medicine!

In this webinar, you will get to know how an innovative adaptive design can increase the probability of success of your early phase clinical trial as well as hear the latest and greatest of the Machine Learning workstream from the Biomarkers ESIG.

PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives

This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution.

PSI Medical Statistics Careers Event

This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.

PSI Career Young Virtual Meet (Q4 2023)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Webinar(s): Causal inference in Clinical Trials

Over the course of two sessions, a panel of 8 esteemed speakers will give an introduction to the topic, followed by a presentation of case studies & interactive panel discussion.