The use of Centralised Statistical Monitoring and Quality Tolerance Limits are fundamental components of Risk Based Quality Management as laid out in ICH-E6(R2) Good Clinical Practice. However, although there has been much commentary published on the operational application of Central Monitoring & QTLs, there appears to be a gap in the literature for the more detailed statistical methodologies that can be utilized.
The Central Statistical Monitoring / Quality Tolerance Limits - Special Interest Group (CSM SIG) has formed itself to create a forum to collaborate and discuss statistical strategies and methodology by;
If you’re interested in learning more &/or joining the CSM SIG please contact the SIG Co-chairs: Susan Talbot & Tim Rolfe.
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 are starting a book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.
Learn from others in the PSI Community who also associate with Imposter Syndrome. They will discuss the topic, give their own personal views and experiences and provide tips to beat it.
Complex Innovative Designs: overview and case studies from FDA pilot program and considerations on master protocols.
Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants.
R is quickly gaining popularity within the pharmaceutical industry due to it being a very powerful object-orientated language, and is able to produce analyses and high quality graphics. This will be a hands-on interactive course and will utilise the RStudio Cloud development environment.
In just 1 hour, learn about the field of medical statistics and how it plays a crucial role in developing ground-breaking new medicines, vaccines and healthcare products.
Overview and Recent methodological Advances for Identifying Treatment Effect Heterogeneity in Clinical Trials.
Building on the previous webinar series we will present a refresher on the key elements of the estimand framework and use the ETHOS study.
Our annual PSI Medical Statistics Careers Event, will be held online on Wednesday 2nd March 2022. The event will include a live online panel discussion and a virtual exhibition session.
For our global team in Europe we are seeking highly qualified candidates to fill the position of Global Director Biostatistics (m/f/x).
Joining us as Principal Biostatistician you will be responsible for providing statistical support of global clinical development programs in neuroscience.
The Senior Manager Biostatistics will be responsible for leading biostatistics strategy and activities for a compound and/or for individual clinical studies.
Novartis is establishing a virtual Analytics Network in the UK and we are currently recruiting PhD graduates to join this exciting new group!
