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.
The field of data visualization is the intersection of data journalism, statistics, graphic design, computer science, neuroscience, and cognitive psychology. We will focus on the latter two fields of data visualization as it relates to data visualization: neuroscience and cognitive psychology.
Hear about potential strategies to handle non-proportional hazards and delayed treatment effects from experts in the field.
At this meeting we will present the evolution of missing data approaches, looking at how they have been handled in the past, the current established missing data approaches and the impact of the new ICH E9 R1 addendum on the handling of missing data, focussing in particular on the treatment policy estimand.
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.
As a statistician in the Biostatistics and Programming Department, you will be responsible for the methodological and statistical aspects of projects in early clinical development in order to optimize the early development plan and ensure its coherence.
As a Director of Statistics, you will be accountable for guiding statisticians in their work, performing senior review of documentation and output deliveries, providing oversight and advising on best practices approach to statistics for clinical trials.
This position provides expert statistical input and project management for statistical activities in relation to clinical trials and statistical activities executed by the Consumer Healthcare division
