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
PSI Introduction to Industry Training (ITIT) Course - 2026/2027
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.
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 webinar brings together three bitesize complementary sessions to help PSI contributors create conference presentations and posters that communicate clearly and inclusively. Participants will explore how to refine their message, prepare materials effectively, and adopt practical habits that support confident, accessible delivery. A focused, supportive session designed to elevate every contribution.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.
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.
Join our Health Technology Assessment (HTA) European Special Interest Group (ESIG) for a webinar on the strategic role of statisticians in the Joint Clinical Assessment (JCA). The introduction of the JCA marks a new era for evidence generation and market access in Europe. As HTA requirements become more harmonized and methodologically demanding, the role of statisticians has evolved far beyond data analysis. Today, statistical expertise is central to shaping clinical development strategies, designing robust comparative evidence, and ensuring that submissions withstand the scrutiny of EU-level assessors. In this webinar, we explore how statisticians contribute strategically to successful JCA outcomes.
Statisticians in the Age of AI: On Route to Strategic Partnership
A 90-minute webinar featuring two case studies from Bayer and Roche demonstrating how statisticians successfully integrated into AI programs, followed by interactive discussion on strategies for elevating statistical expertise in the AI era.
Enhancing Clinical Study Reporting with the Estimand Framework
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
• Understand the role of estimands in improving transparency and interpretation of trial results.
• Navigate common challenges in implementing the framework during reporting.
• Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
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 networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
GSK - Statistics Director - Vaccines and Infectious Disease
We are seeking an experienced and visionary Statistics Director to join our Team and lead strategic statistical innovation across GSK’s Vaccines and Infectious Disease portfolio.
As a Senior Biostatistician I at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
As a Statistical Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
We have an exciting opportunity for an Associate Director, Biostatistics to join a passionate team within Advanced Quantitative Sciences – Full Development.
: We have an exciting opportunity for an Associate Director (AD), Statistical Programming, to join a passionate team within Advanced Quantitative Sciences- Development.
Novartis - Senior Principal Statistical Programmer
We have an exciting opportunity for a Senior Principal Statistical Programmer, to join a passionate team within Advanced Quantitative Sciences – Development.
Pierre Fabre - Clinical Development Safety Statistics Expert M/F
We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31, Oncopole) or Boulogne (92).
Pierre Fabre - Lead Statistician – Real World Evidence -CDI- M/F
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne.
Pierre Fabre - Lead Statistician- Clinical Trials M/F
We are seeking a highly skilled and experienced Lead Statistician in Clinical Trials to join our Biometry Department based in Toulouse (31, Oncopole) or Boulogne (92).
We are looking for Senior Statistical Programmers in the UK to join Veramed, where you'll deliver high-impact programming solutions in an FSP-style capacity, while advancing your career in a supportive, growth-driven environment.