Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
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.
