Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Scientific Meetings
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Training Courses
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Journal Club
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Webinars
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Careers Meetings
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
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.
