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.
The Benefit-Risk ESIG was formed in 2012 with the vision to ensure industry professionals understood and effectively utilize Benefit-Risk methods throughout the entire medicinal product lifecycle process. The group is open to professionals from industry, academia, and public bodies (including regulatory and HTA agencies).
We welcome new members and collaborators! Please reach out to Shahrul Mt-Isa or Marco Boeri if you have an interest in being involved in this ESIG, or have an interesting case study or experience of carrying out a structured Benefit-Risk assessment to share.
We are delighted to share the news about the recent publication of the CIOMS Working Group XII report on Benefit-Risk Balance for Medicinal Products in May 2025.
This report provides insights into the methods used to evaluate the
benefit-risk (BR) balance of a medicinal product. A favourable BR profile must
be established for all medicinal products prior to marketing. This balance must
be reassessed periodically in the post-marketing setting when new information
regarding the benefits and risks, or the landscape of their application,
becomes available. Two new points of emphasis include: (1) transitioning
benefit-risk evaluation from a post-hoc exercise to a comprehensively
integrated element of clinical trial design and conduct, and (2) a pragmatic
patient-centric approach to benefit-risk assessment to ensure proper reflection
and evaluation of the benefits and harms as experienced by patients. This
report builds on the foundations of the CIOMS Working Group IV report published
in 1998, and entitled: Benefit-Risk Balance for Marketed Drugs: Evaluating
Safety Signals; and expands to BR management throughout a product’s lifecycle
using structured approaches and updated methodologies. Presentations on the
report and its recommendations at various scientific conferences and webinar
series are being planned and are subject to future communications.
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.
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.
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.
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.
We are currently seeking a Biostatistician II to join our diverse and dynamic team.
We are currently seeking a Pharmacometrician to join our diverse and dynamic team.
As a Principal Biostatistician, you will lead the statistical strategy and delivery for Phase I–III oncology trials.
As a Senior Biostatistician I at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
As a Statistical Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
We’re seeking a dynamic and visionary leader to join us as Head of Projects - a pivotal role with full ownership of our Projects Division.
We are looking for Senior Statistical Programmers in the UK to join Veramed, where you'll deliver high-impact programming solutions in an FSP-style capacity, while advancing your career in a supportive, growth-driven environment.