Date: Tuesday 14th & Wednesday 15th November 2023 Time: 09:00-17:00 each day Location:This Course will be taught in person, at De Morgan House, 57-58 Russell Square, London WC1B 4HS Speaker: Professor Steven A Julious (Section Director and NIHR Senior Investigator at The University of Sheffield.)
Who is this event intended for? Statisticians working in clinical trials looking to learn about sample size calculations for different types of trial outcomes and study objectives. What is the benefit of attending? The study is a practical course based on real world calculations where participants will be able to come away understanding how to calculate their own sample sizes depending on the type of clinical trial design. Participants will also be introduced to how some estimates used in the calculations are obtained. There will be an opportunity for attendees also to meet and network with other attendees across the industry.
Cost
PSI Members = £320+VAT Non-Members = £430*+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2024.
Registration
To book your place, please click here. Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. Some hotels local to the venue are: President Hotel, Beauchamp Hotel, Mercure and Imperial Hotels.
Overview
The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
Agenda
There will be 4 sessions per day, each between 1.30-2.00 hours. A session will consist of both lectures and practicals, involving calculators or other calculation devices.
Day 1
After introductions the course will give a background to sample size calculations and then go on to cover sample sizes in superiority trials with Normal and binary data, ending the day with trials based on precision. Each lecture will be based on a hands on practical of the methods.
Day 2
The day will begin with sample sizes for cross-over trials followed by a practical which will also enforce the lessons from day 1. The course will then cover calculations for non-inferiority and equivalence trials as well as trials with ordinal data and trials with survival data. It will then move on to more advanced topics of sample sizes for pilot trials and the design of trials which will be adaptive, ending the day with further statistical considerations in the design of studies.
Presenter details
Speaker
Biography
Steven A Julious, Professor of Medical Statistics, has over 30 years of applied experience in medical statistics in both industry and the academic setting with an interest in all aspects of clinical trials from molecule through to the marketplace. His main research focus is clinical trial design and the development of applied methods related to clinical trials. The methodologies around sample size estimation are a particular interest and as well as a book, the second edition of which has just been published, Steven has developed a mobile app for the calculations called SampSize.
Scientific Meetings
PSI Training Course: Sample Sizing for Clinical Trials
Date: Tuesday 14th & Wednesday 15th November 2023 Time: 09:00-17:00 each day Location:This Course will be taught in person, at De Morgan House, 57-58 Russell Square, London WC1B 4HS Speaker: Professor Steven A Julious (Section Director and NIHR Senior Investigator at The University of Sheffield.)
Who is this event intended for? Statisticians working in clinical trials looking to learn about sample size calculations for different types of trial outcomes and study objectives. What is the benefit of attending? The study is a practical course based on real world calculations where participants will be able to come away understanding how to calculate their own sample sizes depending on the type of clinical trial design. Participants will also be introduced to how some estimates used in the calculations are obtained. There will be an opportunity for attendees also to meet and network with other attendees across the industry.
Cost
PSI Members = £320+VAT Non-Members = £430*+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2024.
Registration
To book your place, please click here. Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. Some hotels local to the venue are: President Hotel, Beauchamp Hotel, Mercure and Imperial Hotels.
Overview
The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
Agenda
There will be 4 sessions per day, each between 1.30-2.00 hours. A session will consist of both lectures and practicals, involving calculators or other calculation devices.
Day 1
After introductions the course will give a background to sample size calculations and then go on to cover sample sizes in superiority trials with Normal and binary data, ending the day with trials based on precision. Each lecture will be based on a hands on practical of the methods.
Day 2
The day will begin with sample sizes for cross-over trials followed by a practical which will also enforce the lessons from day 1. The course will then cover calculations for non-inferiority and equivalence trials as well as trials with ordinal data and trials with survival data. It will then move on to more advanced topics of sample sizes for pilot trials and the design of trials which will be adaptive, ending the day with further statistical considerations in the design of studies.
Presenter details
Speaker
Biography
Steven A Julious, Professor of Medical Statistics, has over 30 years of applied experience in medical statistics in both industry and the academic setting with an interest in all aspects of clinical trials from molecule through to the marketplace. His main research focus is clinical trial design and the development of applied methods related to clinical trials. The methodologies around sample size estimation are a particular interest and as well as a book, the second edition of which has just been published, Steven has developed a mobile app for the calculations called SampSize.
Training Courses
PSI Training Course: Sample Sizing for Clinical Trials
Date: Tuesday 14th & Wednesday 15th November 2023 Time: 09:00-17:00 each day Location:This Course will be taught in person, at De Morgan House, 57-58 Russell Square, London WC1B 4HS Speaker: Professor Steven A Julious (Section Director and NIHR Senior Investigator at The University of Sheffield.)
Who is this event intended for? Statisticians working in clinical trials looking to learn about sample size calculations for different types of trial outcomes and study objectives. What is the benefit of attending? The study is a practical course based on real world calculations where participants will be able to come away understanding how to calculate their own sample sizes depending on the type of clinical trial design. Participants will also be introduced to how some estimates used in the calculations are obtained. There will be an opportunity for attendees also to meet and network with other attendees across the industry.
Cost
PSI Members = £320+VAT Non-Members = £430*+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2024.
Registration
To book your place, please click here. Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. Some hotels local to the venue are: President Hotel, Beauchamp Hotel, Mercure and Imperial Hotels.
Overview
The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
Agenda
There will be 4 sessions per day, each between 1.30-2.00 hours. A session will consist of both lectures and practicals, involving calculators or other calculation devices.
Day 1
After introductions the course will give a background to sample size calculations and then go on to cover sample sizes in superiority trials with Normal and binary data, ending the day with trials based on precision. Each lecture will be based on a hands on practical of the methods.
Day 2
The day will begin with sample sizes for cross-over trials followed by a practical which will also enforce the lessons from day 1. The course will then cover calculations for non-inferiority and equivalence trials as well as trials with ordinal data and trials with survival data. It will then move on to more advanced topics of sample sizes for pilot trials and the design of trials which will be adaptive, ending the day with further statistical considerations in the design of studies.
Presenter details
Speaker
Biography
Steven A Julious, Professor of Medical Statistics, has over 30 years of applied experience in medical statistics in both industry and the academic setting with an interest in all aspects of clinical trials from molecule through to the marketplace. His main research focus is clinical trial design and the development of applied methods related to clinical trials. The methodologies around sample size estimation are a particular interest and as well as a book, the second edition of which has just been published, Steven has developed a mobile app for the calculations called SampSize.
Journal Club
PSI Training Course: Sample Sizing for Clinical Trials
Date: Tuesday 14th & Wednesday 15th November 2023 Time: 09:00-17:00 each day Location:This Course will be taught in person, at De Morgan House, 57-58 Russell Square, London WC1B 4HS Speaker: Professor Steven A Julious (Section Director and NIHR Senior Investigator at The University of Sheffield.)
Who is this event intended for? Statisticians working in clinical trials looking to learn about sample size calculations for different types of trial outcomes and study objectives. What is the benefit of attending? The study is a practical course based on real world calculations where participants will be able to come away understanding how to calculate their own sample sizes depending on the type of clinical trial design. Participants will also be introduced to how some estimates used in the calculations are obtained. There will be an opportunity for attendees also to meet and network with other attendees across the industry.
Cost
PSI Members = £320+VAT Non-Members = £430*+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2024.
Registration
To book your place, please click here. Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. Some hotels local to the venue are: President Hotel, Beauchamp Hotel, Mercure and Imperial Hotels.
Overview
The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
Agenda
There will be 4 sessions per day, each between 1.30-2.00 hours. A session will consist of both lectures and practicals, involving calculators or other calculation devices.
Day 1
After introductions the course will give a background to sample size calculations and then go on to cover sample sizes in superiority trials with Normal and binary data, ending the day with trials based on precision. Each lecture will be based on a hands on practical of the methods.
Day 2
The day will begin with sample sizes for cross-over trials followed by a practical which will also enforce the lessons from day 1. The course will then cover calculations for non-inferiority and equivalence trials as well as trials with ordinal data and trials with survival data. It will then move on to more advanced topics of sample sizes for pilot trials and the design of trials which will be adaptive, ending the day with further statistical considerations in the design of studies.
Presenter details
Speaker
Biography
Steven A Julious, Professor of Medical Statistics, has over 30 years of applied experience in medical statistics in both industry and the academic setting with an interest in all aspects of clinical trials from molecule through to the marketplace. His main research focus is clinical trial design and the development of applied methods related to clinical trials. The methodologies around sample size estimation are a particular interest and as well as a book, the second edition of which has just been published, Steven has developed a mobile app for the calculations called SampSize.
Webinars
PSI Training Course: Sample Sizing for Clinical Trials
Date: Tuesday 14th & Wednesday 15th November 2023 Time: 09:00-17:00 each day Location:This Course will be taught in person, at De Morgan House, 57-58 Russell Square, London WC1B 4HS Speaker: Professor Steven A Julious (Section Director and NIHR Senior Investigator at The University of Sheffield.)
Who is this event intended for? Statisticians working in clinical trials looking to learn about sample size calculations for different types of trial outcomes and study objectives. What is the benefit of attending? The study is a practical course based on real world calculations where participants will be able to come away understanding how to calculate their own sample sizes depending on the type of clinical trial design. Participants will also be introduced to how some estimates used in the calculations are obtained. There will be an opportunity for attendees also to meet and network with other attendees across the industry.
Cost
PSI Members = £320+VAT Non-Members = £430*+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2024.
Registration
To book your place, please click here. Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. Some hotels local to the venue are: President Hotel, Beauchamp Hotel, Mercure and Imperial Hotels.
Overview
The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
Agenda
There will be 4 sessions per day, each between 1.30-2.00 hours. A session will consist of both lectures and practicals, involving calculators or other calculation devices.
Day 1
After introductions the course will give a background to sample size calculations and then go on to cover sample sizes in superiority trials with Normal and binary data, ending the day with trials based on precision. Each lecture will be based on a hands on practical of the methods.
Day 2
The day will begin with sample sizes for cross-over trials followed by a practical which will also enforce the lessons from day 1. The course will then cover calculations for non-inferiority and equivalence trials as well as trials with ordinal data and trials with survival data. It will then move on to more advanced topics of sample sizes for pilot trials and the design of trials which will be adaptive, ending the day with further statistical considerations in the design of studies.
Presenter details
Speaker
Biography
Steven A Julious, Professor of Medical Statistics, has over 30 years of applied experience in medical statistics in both industry and the academic setting with an interest in all aspects of clinical trials from molecule through to the marketplace. His main research focus is clinical trial design and the development of applied methods related to clinical trials. The methodologies around sample size estimation are a particular interest and as well as a book, the second edition of which has just been published, Steven has developed a mobile app for the calculations called SampSize.
Careers Meetings
PSI Training Course: Sample Sizing for Clinical Trials
Date: Tuesday 14th & Wednesday 15th November 2023 Time: 09:00-17:00 each day Location:This Course will be taught in person, at De Morgan House, 57-58 Russell Square, London WC1B 4HS Speaker: Professor Steven A Julious (Section Director and NIHR Senior Investigator at The University of Sheffield.)
Who is this event intended for? Statisticians working in clinical trials looking to learn about sample size calculations for different types of trial outcomes and study objectives. What is the benefit of attending? The study is a practical course based on real world calculations where participants will be able to come away understanding how to calculate their own sample sizes depending on the type of clinical trial design. Participants will also be introduced to how some estimates used in the calculations are obtained. There will be an opportunity for attendees also to meet and network with other attendees across the industry.
Cost
PSI Members = £320+VAT Non-Members = £430*+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2024.
Registration
To book your place, please click here. Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. Some hotels local to the venue are: President Hotel, Beauchamp Hotel, Mercure and Imperial Hotels.
Overview
The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
Agenda
There will be 4 sessions per day, each between 1.30-2.00 hours. A session will consist of both lectures and practicals, involving calculators or other calculation devices.
Day 1
After introductions the course will give a background to sample size calculations and then go on to cover sample sizes in superiority trials with Normal and binary data, ending the day with trials based on precision. Each lecture will be based on a hands on practical of the methods.
Day 2
The day will begin with sample sizes for cross-over trials followed by a practical which will also enforce the lessons from day 1. The course will then cover calculations for non-inferiority and equivalence trials as well as trials with ordinal data and trials with survival data. It will then move on to more advanced topics of sample sizes for pilot trials and the design of trials which will be adaptive, ending the day with further statistical considerations in the design of studies.
Presenter details
Speaker
Biography
Steven A Julious, Professor of Medical Statistics, has over 30 years of applied experience in medical statistics in both industry and the academic setting with an interest in all aspects of clinical trials from molecule through to the marketplace. His main research focus is clinical trial design and the development of applied methods related to clinical trials. The methodologies around sample size estimation are a particular interest and as well as a book, the second edition of which has just been published, Steven has developed a mobile app for the calculations called SampSize.
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