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.
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.
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.
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.
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.
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
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
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 Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
PSI Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK