Pre-Clinical SIG

We are a group of statisticians working at CROs and pharmaceutical industry supporting preclinical drug discovery on animal and cell based experiments. As a group, our focus is on diverse range of preclinical topics such as;

  • Discovery
  • Robust study design/good statistical practices in in-vitro, ex-vivo and in-vivo assay development
  • Reproducibility and Translation from pre-clinical to clinical
  • Toxicogenomics
  • General Toxicology
  • Eco-Toxicology
  • Toxicokinetics
  • DMPK / Pharmacokinetics
  • ECG
  • Immuno Toxicology
  • Histopathology
  • Pharmacology
  • Developmental and Reproductive Toxicology
  • Carcinogenicity

 

We organise webinars and workshops on topics and methodological developments in preclinical research and now have a list of over 50 affiliates on our e-mail distribution list. 

 

 

 

 

  Core Committee (L-R): (* not present in the picture)

Preclinical SIG
  NameCompany/Institution
  Denise FedericoEvotec   
  Luc Essermeant Sanofi
  Eloisa BrookGSK (chair)
  Dorothee Tamarelle Sanofi

Jan Serroyen*

Janssen

  Bernd Igl*

Boehringer Ingelheim

  Ezgi Tanriver-Ayder*

GSK

Helena Geys*Janssen

 

 

 

 

 

Purpose

We see our mission as bridging preclinical knowledge and expertise within the pharmaceutical industry and academia to provide a forum to collaborate, discuss and advance statistical topics related to Research, Discovery (including efficacy models), Regulatory and Investigative Toxicology/Safety Assessment. We also hope to encourage the development of relevant statistical methodologies and promote the involvement of statisticians in these areas.

Find out more about us and our objectives in our video overview:

 

Pre-Clinical SIG Webinars

PSI Pre-clinical Special Interest Group has a series of regular FREE webinars dealing with statistical topics faced in pre-clinical and related fields. The presentations run for an hour, with approximately 45 min presentation and a Q&A session in the remaining time. See section below for details of this webinars. Please note that these events take place online via Zoom, and have a limited number of places available. 


2026 Webinars

The PSI Pre-Clinical Special Interest Group seminars for 2026 are planned as follows:

 

Date

Title

Presenter

 

3 February 2026

Multi-Group Comparison of Means for Single-Factor Experiment with Small Sample Size Under Normality and Heteroscedasticity 
Weiliang Qiu, SanofiTo access video on demand, click here
5 May 2026Connecting the False Discovery Rate to Shrunk EstimatesNick Galwey, GSK (Retired) To access video on demand, click  here

 

 

2025 Webinars

The PSI Pre-Clinical Special Interest Group seminars for 2025 were as follows: 

Date

Title

Presenter

 

19 March 2025

AI in Medicinal Products

 Dr Liam Childs, AI working group lead - Paul Ehrlich Institute

To access video on demand, click here
24 June 2025

Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

Rachel Heyard,
Postdoctoral Fellow at Center for Reproducible Science, University of Zurich

To access video on demand, click here
23 September 2025AI agents for drug discovery and development
James Zou,
Associate professor of Biomedical Data Science at Stanford University
To access video on demand, click here

18 November 2025Randomization in Pre-Clinical Studies: When Evolution Theory Meets StatisticsDavit Sargsyan, Johnson & Johnson Pharmaceutical, Spring House, Pennsylvania, USATo access video on demand, click here

Workshops

Workshop 2026, Berlin jointly with IBS- DR Working Group Non-Clinical Statistics 

Registration for our workshop on 26-27th November in Berlin, Germany will be open soon and free!

                                                   

This workshop in collaboration with IBS-DR Working Group Nonclinical Statistics and IBS-DR Working Group Ethics and Responsibility and will take place over one and a half-days, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical researchers.

This year's workshop focuses on reproducibility, translatability, and methodological advancements in pre-clinical studies, with dedicated panel discussion on How to Improve the Reproducibility of Animal Experiments with experts from academia and industry on the topic. The agenda will include invited presentations, interactive round discussions, and ample opportunities for networking and collaboration, both during structured sessions and informal social events.

The event is designed to foster knowledge exchange, encourage cross-sector dialogue, and support the development of best practices in the evolving landscape of pre-clinical research.

Please submit abstracts and register by October 15, 2026 via email to bernd-wolfgang.igl@boehringer-ingelheim.com, frank.konietschke@charite.de or lauseker@ibe.med.uni-muenchen.de.

Workshop 2024, Paris

We held our first face-to-face workshop since 2019 in Paris this year. It was wonderful to connect with old and new faces.There was great engagement in the sessions; we all learnt something and had fun too!

Day

Title

Presenter(s)

1

Application of experimental design in animal research: theory and practice 

Simon Bate, GSK

2Analysing Pre-clinical experiments 

Odile Coudert, Ipsen & Bernard Franq, GSK

 Statistics in Toxicology 

Philip Jarvis, Novartis & David Lovell, University of London

 

 

Workshop 2024

 

 

How to get in touch

Please email us if you are interested in contributing to PSI Preclinical SIG or would like to join our mailing list.


EFSPI_Logo

Upcoming Events

PSI Book Club: Change: How organisations achieve hard-to-imagine results in uncertain and volatile times

Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change. Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization. Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.

PSI Training Course: Adaptive Designs

This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.

PSI Vaccines SIG Webinar: Statistical Immune Correlate Analysis of Hemagglutination Inhibition Titers for an mRNA-based Influenza Vaccine

This 1-hour webinar is designed for statisticians with an interest in vaccine development, to learn about the recent application of statistical immune correlate analysis in vaccine development. Specifically, an application of such analyses to evaluate hemagglutination inhibition titers for an influenza vaccine

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

Date: Wednesday 4th November 2026 A careers talk about medical statistics and how it plays a crucial role in developing new medicines. Learn about the field of medical statistics and how it plays a crucial role in developing groundbreaking new medicines, vaccines and healthcare products.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

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 Medical Statistics Student Careers Event 2026

Date: 18 November 2026 This is an excellent opportunity for students to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future. All students currently studying for a mathematics or statistics-related BSc, MSc or PhD are invited to attend, and we welcome interest from exhibitors too.

AIMS SIG - Open-Source Lunch Bites

Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.

Aligning Estimation with the Clinical Question of Interest

This webinar will focus on aligning estimation to estimands. How do different strategies for handling intercurrent events and missing data handling influence the choice of estimation method, with illustration using a case study.

PSI Career Young Virtual Event (Q4 2026)

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 Careers Coaching Series: Peer Support Initiative

This 10-month peer support programme is aimed at professionals with five or more years of experience who are seeking structured development and connection with peers at a similar career stage. Through 5 bi-monthly topics, participants will engage in coach-led presentations, small-group discussions, and regular progress reviews focused on achieving tangible outcomes.

Latest Jobs

Amgen - HTA Biostatistics Manager

In this vital role you will generate evidence to meet Health Technology Assessment (HTA) requirements, while ensuring that the analyses performed meet required standards and are robust and valid.

MMS Holdings - Senior Biostatistician (UK)

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?

Novartis - Statistics/Programming/Data Science Industrial Placement Programme

What if your placement year meant more than observing from the sidelines? Join Novartis and spend 12 months working hands-on with real clinical trial and healthcare data, helping to advance medicines that could improve patients' lives.

Phastar – Associate Director, Statistics – Real World Evidence (RWE)

As an Associate Director, Statistics (RWE) you will focus on supporting one of our key pharmaceutical clients within our FSP function. This will be a hands-on technical role, with oversight responsibilities and cross-functional exposure.

Phastar – Principal Statistician – Real World Evidence (RWE)

We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at Principal level.

Phastar – Senior / Principal Statistician

We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at either Senior or Principal levels.