PSI Strategic Plan 2025–2027
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RSS & PSI - Joint Letter to Baroness Smith

Government Proposals on Age Restrictions for Level 7 Apprenticeships

PSI and the RSS have jointly written to Baroness Smith to raise concerns about recent changes to Level 7 Apprenticeship age limits. These restrictions risk significantly reduce opportunities for people entering or retraining in the statistics profession, strongly impacting the industry. The letter asks the government to reconsider this decision to ensure the continued growth and diversity of the UK’s statistical workforce. 

Click Here to view the letter.

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.

AIMS SIG - Open-Source Lunch Bites

Topic: R Package Basics. 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. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.

PSI Mentoring 2026

Date: Ongoing 6 month cycle beginning late April/early May 2026 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.

PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence

If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.

PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities

This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.

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,

Medical Devices

We focus on statistical methods for medical devices development and post-market follow-up. 

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.