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We are a community dedicated to leading and promoting the use of statistics within the healthcare industry for the benefit of patients.
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Upcoming Events
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 Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
PSI Journal Club: Randomization
Date: Tuesday 9th September 2025 Join us to hear Sofia Weigle and Weng-Kee Wong present their recent work.
PSI Training Course: Pediatric Extrapolation
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
PSI Career Young Virtual Event (Q3 2025)
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Pre-Clinical SIG Webinar: AI agents for drug discovery and development
AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.
EFSPI/PSI Causal Inference SIG Webinar: Instrumental Variable Methods
The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.
PSI Pre-Clinical Workshop - October 2025
The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.
PSI Training Course: Introduction to Machine Learning
Four sessions will include ML foundation (including an introduction, data exploration for ML and dimensionality reduction and feature selection), Supervised learning (including support vector machines and model evaluation and interpretation), model optimization and unsupervised learning (including clustering) and advanced topics (including neural networks, deep learning and large language models).
PSI/EFSPI Vaccines Statistics Workshop
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics
Date: Wednesday 5th November 2025 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
PSI Medical Statistics Student Careers Event 2025
Date: 19 November 2025 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 Event (Q4 2025)
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Special Interest Groups
AI and ML
For clinical research statisticians, where specifically are AI & ML useful – considering regulatory requirements.
AIMS
When it comes to R and open-source in the Pharma industry, we would like to point you in the right direction!
Benefit-Risk
The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.
Biomarkers
The PSI / EFSPI Biomarkers Special Interest Group has been formed with the aim of developing knowledge and opinions within the statisticians about biomarker usage and the related statistical and study design techniques that are involved.
Causal Inference
Apply advances in causal inference methodology to address industry applications in RCT’s, while taking into account the framework of ICH, e.g. E9(R1), as well as guidelines from health authorities...
CMC Statistical Network Europe
Chemistry, Manufacturing and Control Statisticians, working in Europe for pharmaceutical companies and CROs active in R&D, and we seek to collaborate and exchange in any precompetitive topic of our field.
CSM/QTL
The CSM/QTL SIG is a joint collaboration including PSI, ASA BIOP & EFSPI providing a forum to discuss strategies and methodology with other interested parties in Centralised Statistical Monitoring and Quality Tolerance Limits
Data Science
Bridging Data Science knowledge and expertise across various groups and functions within the pharmaceutical industry to increase collaboration, awareness, knowledge sharing and enhance drug development. We’ll encourage the development of new statistical and machine learning methods and approaches as well as in novel applications of the well-established methods.
Data Sharing
Sharing experiences and challenges of external patient level data sharing with particular focus on data privacy and anonymization processes.
Decision Making
The Quantitative Decision-making Special Interest Group (QDM SIG) was formed in October 2017. It is a group of statisticians from industry and academia, with experience and interests in statistical methods for quantitative decision-making in drug development.
Historical Data
What is the state of the art regarding approaches to incorporate historical data into the formal design and analysis of clinical trials, Which statistical methods should we use to make historical and current data comparable, What are the regulatory requirements necessary for the acceptance of historical data in drug approval?
HTA
The purpose of the Healthcare Technology Assessment SIG is to provide statisticians working in the Pharmaceutical Industry engaged in Health Technology Assessments, and others in related fields of research...
Launch & Lifecycle
Providing a platform for statisticians from sponsors and CROs to working in the launch and lifecycle management (including traditional medical affairs area,
Neuroscience-Estimands
This SIG will connect the following two topics: general biostatistics Neuroscience community, and working groups on estimands & other topics in Neuroscience.
Oncology-Estimands
The draft addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in August 2017 and introduced an estimand framework. In February 2018, Evgeny Degtyarev from Novartis and Kaspar Rufibach from Roche started an informal working group to discuss how to implement the draft addendum in oncological clinical trials.
Patient-Focused Drug Development
The purpose of the PFDD SIG is to connect statisticians in pharmaceutical industry roles who work on progressing the inclusion of patient-reported outcomes (PROs) and clinical outcome assessments (COAs) across all phases of drug development process to share their knowledge and also lead statistical thinking and methods to solve common statistical challenges of use of COAs in drug development.
Pre-clinical
To provide a forum to discuss the statistical issues involved in Regulatory and Investigative Toxicology.
Randomisation
Our passion is to change the way randomisation is considered and performed in clinical trials.
Regulatory
The regulatory SIG co-ordinates regulatory activities across the European Pharmaceutical Statistical community and to engage with European Regulatory statisticians.
RWD
A special interest group to increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.
Small Populations
The SIG “Small populations” provides a forum for identifying and discussing statistical methodology related to clinical development of treatments in small populations, and for sharing experiences.
Software Engineering
Welcome to the home page of openstatsware, a.k.a. the Software Engineering special interest group! Our primary goals are to: Collaborate to engineer selected R-packages and Develop best practices for engineering high-quality statistical software.
Treatment Effect Heterogeneity
Treatment Effect Heterogeneity is routinely conducted in drug development, in various settings; one key aspect is the regulatory requirement to demonstrate consistency of treatment effect across a pre-defined set of subgroups (e.g., ICHE5, E9, E17).
Vaccines
Creating a professional platform for statisticians in the Pharmaceutical industry, Regulatory agencies and Public Health organizations working on the research and development of vaccines to understand how best to apply methodologies.
Visualisation
Effective visualisation of data should belong to the core skills of statisticians as it represents an essential tool in exploring data as well as explaining data.
Statisticians in the Pharmaceutical Industry Executive Office:
St James House | Vicar Lane | Sheffield | S1 2EX | UK
St James House | Vicar Lane | Sheffield | S1 2EX | UK
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