Best of PSI 2019
The sessions included early-phase innovative trial design, industry best practices, statistical issues in safety drug labeling, model-based dose-finding designs, an update from Transcelerate, and much more.
The sessions included early-phase innovative trial design, industry best practices, statistical issues in safety drug labeling, model-based dose-finding designs, an update from Transcelerate, and much more.
Processes are made to minimize mistakes and their different processes were set up to deal with mistakes and help you when mistakes occur.
Today’s episode will give you insights into 7 mistakes in presentations. Honestly, I see at least one of them in nearly every presentation and I struggle with them as well – just listen to this episode and you’ll have a live example.
For any statistician a job change represent a major shift and occurs rather infrequent – hopefully. For a recruiter – this is day-to-day business.
In this interview with Katie Thorn and Claire Brittain, we’re exploring factors, which help to make it a win for both sides. Both have worked very well together and shared their stories.
While most of our day-to-day activities consist of running clinical studies, submissions, and directly related work, we also engage in such innovation work streams or process improvement working groups and other such activities.
As statisticians in the medical field, we’re used to studying subgroups of patients with respect to all kinds of biological variables: from demographics to genomics. This provides us with a good understanding of what the benefit-risk profile for a given patient looks like.
In todays episode, we speak with Michael O’Kelly, an expert on this topic with lots of presentations around estimand (see e.g. the PSI events). He also won the award for Statistical Excellence in the Pharmaceutical Industry, jointly run by the RSS and Statisticians in the Pharmaceutical Industry (PSI).
I’m sure, we all face this situation sooner or later, and not surprisingly lots of research has happened in the last years in this area. In today’s episode, we will help you to understand one of the best approaches I have come across to solve this problem in a rigorous yet sophisticated way: the SIDES approach.
How many details do you need to have to call an analysis pre-specified? Should we label a request to analyze a certain subgroup by regulators as well as a fishing expedition to find a significant subgroup both in the same way: post-doc?