Our last event of 2015, sponsored by Wiley, was held in mid-December 2015, on the topic of Go/NoGo Decision Rules and Probability of Program Success. We were pleased to coordinate with the DIA for this event, with speakers from Pharmaceutical Statistics and Therapeutic Innovation & Regulatory Science. Listen again or catch up on the event here.
DIA Chair: Tad Archambault, Virtu Stat, Ltd.
Speaker: Ming Zhou, Amylin Pharmaceuticals
A Novel Design for Decision Rules Based on Statistical Testing Strategies of Binary Endpoints in a Definitive Go/No-Go Single-Treatment Clinical Study
Authors: Ming Zhou and Larry Z. Shen
Therapeutic Innovation & Regulatory Science, Vol. 48, Issue 3, pp. 327-335, 2014
Links: Abstract | Paper+ | Slides
PSI Chair: Sarah Bray, Amgen
Speaker: Meihua Wang, Merck Research Laboratories
Evaluation of program success for programs with multiple trials in binary outcomes
Authors: Meihua Wang, G. Frank Liu, and Jerald Schindler
Pharmaceutical Statistics, Vol. 14, Issue 3, pp. 172–179, 2015
Links: Abstract | Paper+ | Slides
Discussant: Fanhui Kong, FDA
+Papers available to view from December 8th 2015 to January 5th 2016. For the flier advertising the event, please click here.
Upcoming Events
PSI Webinar: Wearable Technologies - Challenges and Opportunities
Wearable technologies and digital health data offer great opportunities for studying patients functionally in real life settings. Actigraphy, for example, can be used as part of clinical trials to collect continuous movement data, but the frequency of data collection results in dense datasets requiring extensive processing and signal detection. In this webinar, a panel of expert speakers will discuss how such aspects can be addressed to help realize the promise of these technologies.
Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.
Discover your extraordinary potential by working as a Covance AD, Biostatistics / Senior Principal Biostatistician. You will consult in the design of complex and innovative studies & clinical trial programs as well as Leading DMC/DSMB processes.
By joining our company, in this role you will apply your skills and experience in support of developing scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives.
Senior Principal / Principal Biostatistician (Oncology) – FSP
Join our team as a Covance FSP Senior Principal or Principal Biostatistician. You will be assigned to one Sponsor working on Phase I and II oncology studies. Previous Lead experience essential. Office or home-based anywhere in Europe or South Africa.
