Date: Thursday 10th December 2020 Time: 15:00 - 16:00 GMT Speaker: Scott Patterson (Sanofi)
Who is this event intended for? Statisticians interested in the statistics of crisis vaccine clinical studies, like those being done for COVID-19.
What is the benefit of attending? Those attending will learn of several statistical observations on crisis vaccine clinical development that are important to an understanding of data generated in COVID-19 vaccine development and other crisis clinical vaccine programs.
Registration
You can now register for this event. Registration will close at 12:00 on 9th December 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.
Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing.
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, will be discussed.
Speaker Details
Speaker
Biography
Scott Patterson (Sanofi)
Scott Patterson PhD, PStat is currently the head of Statistical Innovation at Sanofi Pasteur, the vaccines’ division of Sanofi. He and co-author Professor Byron Jones wrote `Bioequivalence and Statistics in Clinical Pharmacology’ now in its second edition. Scott has over 25 years of professional experience in biostatistics, and he and his family reside in Pennsylvania, USA.
Scientific Meetings
PSI Vaccine SIG Webinar: Some considerations on developing COVID-19 Vaccines
Date: Thursday 10th December 2020 Time: 15:00 - 16:00 GMT Speaker: Scott Patterson (Sanofi)
Who is this event intended for? Statisticians interested in the statistics of crisis vaccine clinical studies, like those being done for COVID-19.
What is the benefit of attending? Those attending will learn of several statistical observations on crisis vaccine clinical development that are important to an understanding of data generated in COVID-19 vaccine development and other crisis clinical vaccine programs.
Registration
You can now register for this event. Registration will close at 12:00 on 9th December 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.
Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing.
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, will be discussed.
Speaker Details
Speaker
Biography
Scott Patterson (Sanofi)
Scott Patterson PhD, PStat is currently the head of Statistical Innovation at Sanofi Pasteur, the vaccines’ division of Sanofi. He and co-author Professor Byron Jones wrote `Bioequivalence and Statistics in Clinical Pharmacology’ now in its second edition. Scott has over 25 years of professional experience in biostatistics, and he and his family reside in Pennsylvania, USA.
Training Courses
PSI Vaccine SIG Webinar: Some considerations on developing COVID-19 Vaccines
Date: Thursday 10th December 2020 Time: 15:00 - 16:00 GMT Speaker: Scott Patterson (Sanofi)
Who is this event intended for? Statisticians interested in the statistics of crisis vaccine clinical studies, like those being done for COVID-19.
What is the benefit of attending? Those attending will learn of several statistical observations on crisis vaccine clinical development that are important to an understanding of data generated in COVID-19 vaccine development and other crisis clinical vaccine programs.
Registration
You can now register for this event. Registration will close at 12:00 on 9th December 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.
Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing.
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, will be discussed.
Speaker Details
Speaker
Biography
Scott Patterson (Sanofi)
Scott Patterson PhD, PStat is currently the head of Statistical Innovation at Sanofi Pasteur, the vaccines’ division of Sanofi. He and co-author Professor Byron Jones wrote `Bioequivalence and Statistics in Clinical Pharmacology’ now in its second edition. Scott has over 25 years of professional experience in biostatistics, and he and his family reside in Pennsylvania, USA.
Journal Club
PSI Vaccine SIG Webinar: Some considerations on developing COVID-19 Vaccines
Date: Thursday 10th December 2020 Time: 15:00 - 16:00 GMT Speaker: Scott Patterson (Sanofi)
Who is this event intended for? Statisticians interested in the statistics of crisis vaccine clinical studies, like those being done for COVID-19.
What is the benefit of attending? Those attending will learn of several statistical observations on crisis vaccine clinical development that are important to an understanding of data generated in COVID-19 vaccine development and other crisis clinical vaccine programs.
Registration
You can now register for this event. Registration will close at 12:00 on 9th December 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.
Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing.
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, will be discussed.
Speaker Details
Speaker
Biography
Scott Patterson (Sanofi)
Scott Patterson PhD, PStat is currently the head of Statistical Innovation at Sanofi Pasteur, the vaccines’ division of Sanofi. He and co-author Professor Byron Jones wrote `Bioequivalence and Statistics in Clinical Pharmacology’ now in its second edition. Scott has over 25 years of professional experience in biostatistics, and he and his family reside in Pennsylvania, USA.
Webinars
PSI Vaccine SIG Webinar: Some considerations on developing COVID-19 Vaccines
Date: Thursday 10th December 2020 Time: 15:00 - 16:00 GMT Speaker: Scott Patterson (Sanofi)
Who is this event intended for? Statisticians interested in the statistics of crisis vaccine clinical studies, like those being done for COVID-19.
What is the benefit of attending? Those attending will learn of several statistical observations on crisis vaccine clinical development that are important to an understanding of data generated in COVID-19 vaccine development and other crisis clinical vaccine programs.
Registration
You can now register for this event. Registration will close at 12:00 on 9th December 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.
Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing.
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, will be discussed.
Speaker Details
Speaker
Biography
Scott Patterson (Sanofi)
Scott Patterson PhD, PStat is currently the head of Statistical Innovation at Sanofi Pasteur, the vaccines’ division of Sanofi. He and co-author Professor Byron Jones wrote `Bioequivalence and Statistics in Clinical Pharmacology’ now in its second edition. Scott has over 25 years of professional experience in biostatistics, and he and his family reside in Pennsylvania, USA.
Careers Meetings
PSI Vaccine SIG Webinar: Some considerations on developing COVID-19 Vaccines
Date: Thursday 10th December 2020 Time: 15:00 - 16:00 GMT Speaker: Scott Patterson (Sanofi)
Who is this event intended for? Statisticians interested in the statistics of crisis vaccine clinical studies, like those being done for COVID-19.
What is the benefit of attending? Those attending will learn of several statistical observations on crisis vaccine clinical development that are important to an understanding of data generated in COVID-19 vaccine development and other crisis clinical vaccine programs.
Registration
You can now register for this event. Registration will close at 12:00 on 9th December 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.
Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing.
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, will be discussed.
Speaker Details
Speaker
Biography
Scott Patterson (Sanofi)
Scott Patterson PhD, PStat is currently the head of Statistical Innovation at Sanofi Pasteur, the vaccines’ division of Sanofi. He and co-author Professor Byron Jones wrote `Bioequivalence and Statistics in Clinical Pharmacology’ now in its second edition. Scott has over 25 years of professional experience in biostatistics, and he and his family reside in Pennsylvania, USA.
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.