In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Scientific Meetings
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Training Courses
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Journal Club
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Webinars
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Careers Meetings
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Upcoming Events
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.
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.
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.
deb2bdff3ad665b3a176ff00001f6b97.tmb-medium.jpg?Culture=en&sfvrsn=1364d8db_1 "Photo Jurgen Hummel (2019)")
