PSI Vaccines SIG Webinar: Assessing Population Level Vaccine Effectiveness Under Different Study Designs

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: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing

This 1-hour webinar will be an opportunity to hear how JMP have been influential in the toxicity testing of an oncology formulation in a pre-clinical setting. At the end of the presentation there will also be the opportunity to ask questions.

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.

Joint PSI/EFSPI Small Populations & RWD SIG Webinar: Harnessing Real-World Data (RWD) in clinical trials for small populations and rare diseases

In this webinar we will review the range of statistical methodologies used to harness the potential of Real-World Data (RWD) in clinical development, particularly in the context of rare diseases and small populations like paediatrics. The session will include theoretical understanding and practical case studies, with a special focus on Bayesian methods and causal inference.

PSI Webinar: Hierarchical composite endpoints in clinical trials: challenges & opportunities

In this event, we’ll start with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations will be illustrated through case studies from clinical trials in heart failure and chronic kidney disease. We conclude with a discussion and a Q&A.

PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

A careers talk about medical statistics and how it plays a crucial role in developing new medicines

Joint PSI/EFSPI Causal Inference SIG Webinar: Opportunities in applying a causal inference framework during the analysis of an RCT

This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.

PSI Training Course: Introduction to Bayesian Methods

This interactive and hands on online course, aimed at beginner Bayesians who have little or no experience in Bayesian statistics, is split into 3 modules. Module 1 introduces Bayesian concepts and looks at how Bayes has been used recently in the Pharmaceutical Industry, and participants will undertake their own data collection exercise in order to analyse a simple Bayesian trial. Module 2 takes a look at the concepts of Bayesian statistics and key terminology and provides a chance to analyse some data using a simple Bayesian approach. Module 3 takes a further look at the use of Bayesian statistics in drug development and regulatory requirements and digs deeper into analysis issues.

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.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Speaker	Biography
Mohammad Ali	In 1984, I started my research career at the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B) focusing on data management and statistical analysis of a large clinical trial. Subsequently, I was involved in various studies on population and health at the Center. After completion of my Ph.D. in the field of spatial epidemiology, I joined at the International Vaccine Institute (IVI), Seoul, Korea as the Senior Scientist, and the Head of Biostatistics Unit in early 2001. I introduced Geographic Information System in vaccine evaluation studies for the various research sites of IVI. My spatial epidemiology studies investigated the effectiveness of cholera vaccines, the approach demonstrated that the use of geographic variations in vaccine coverage can help evaluate the indirect protective effects of the vaccine. This method is applicable to trials of a wide range of vaccines before they are introduced into public health practice. In addition, I used GIS, satellite remote sensing, and spatial modeling techniques in research that is grounded in geographic theories of human-environment interaction for generating hypotheses about potential causes of the health problems. I created model for the emergence and fluctuations of cholera by integrating spatial data sets including satellite imagery derived from different sensors, climatic variables, and socio-demographic characteristics (population distribution, and socio-economic status) of the people. In late 2013, I joined at the Johns Hopkins University as a Senior Scientist. At the university, I developed protocols and research studies, published scientific papers, led statistical analysis activities involving multiple institutions, developed data management and statistical analysis plans for the clinical trials, ensured standardization of methods and the quality of the data by assessing and assisting study sites in the design and conduct of the study, mentored MSPH and PhD students, and taught a course on the spatial analysis of health events. Since beginning of 2020, I have working as a Biostatistics lead for pneumococcal franchise at the Pfizer VAC-Medical and involved in scientific data analysis of the various clinical studies around the globe. I am author or co-author of more than 200 publications and book chapters, reviewer of several peer-reviewed journals, Editor of PLoS ONE, and worked as a Research Consultant in several research institutes.

Speaker	Biography
Mohammad Ali	In 1984, I started my research career at the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B) focusing on data management and statistical analysis of a large clinical trial. Subsequently, I was involved in various studies on population and health at the Center. After completion of my Ph.D. in the field of spatial epidemiology, I joined at the International Vaccine Institute (IVI), Seoul, Korea as the Senior Scientist, and the Head of Biostatistics Unit in early 2001. I introduced Geographic Information System in vaccine evaluation studies for the various research sites of IVI. My spatial epidemiology studies investigated the effectiveness of cholera vaccines, the approach demonstrated that the use of geographic variations in vaccine coverage can help evaluate the indirect protective effects of the vaccine. This method is applicable to trials of a wide range of vaccines before they are introduced into public health practice. In addition, I used GIS, satellite remote sensing, and spatial modeling techniques in research that is grounded in geographic theories of human-environment interaction for generating hypotheses about potential causes of the health problems. I created model for the emergence and fluctuations of cholera by integrating spatial data sets including satellite imagery derived from different sensors, climatic variables, and socio-demographic characteristics (population distribution, and socio-economic status) of the people. In late 2013, I joined at the Johns Hopkins University as a Senior Scientist. At the university, I developed protocols and research studies, published scientific papers, led statistical analysis activities involving multiple institutions, developed data management and statistical analysis plans for the clinical trials, ensured standardization of methods and the quality of the data by assessing and assisting study sites in the design and conduct of the study, mentored MSPH and PhD students, and taught a course on the spatial analysis of health events. Since beginning of 2020, I have working as a Biostatistics lead for pneumococcal franchise at the Pfizer VAC-Medical and involved in scientific data analysis of the various clinical studies around the globe. I am author or co-author of more than 200 publications and book chapters, reviewer of several peer-reviewed journals, Editor of PLoS ONE, and worked as a Research Consultant in several research institutes.

Speaker	Biography
Mohammad Ali	In 1984, I started my research career at the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B) focusing on data management and statistical analysis of a large clinical trial. Subsequently, I was involved in various studies on population and health at the Center. After completion of my Ph.D. in the field of spatial epidemiology, I joined at the International Vaccine Institute (IVI), Seoul, Korea as the Senior Scientist, and the Head of Biostatistics Unit in early 2001. I introduced Geographic Information System in vaccine evaluation studies for the various research sites of IVI. My spatial epidemiology studies investigated the effectiveness of cholera vaccines, the approach demonstrated that the use of geographic variations in vaccine coverage can help evaluate the indirect protective effects of the vaccine. This method is applicable to trials of a wide range of vaccines before they are introduced into public health practice. In addition, I used GIS, satellite remote sensing, and spatial modeling techniques in research that is grounded in geographic theories of human-environment interaction for generating hypotheses about potential causes of the health problems. I created model for the emergence and fluctuations of cholera by integrating spatial data sets including satellite imagery derived from different sensors, climatic variables, and socio-demographic characteristics (population distribution, and socio-economic status) of the people. In late 2013, I joined at the Johns Hopkins University as a Senior Scientist. At the university, I developed protocols and research studies, published scientific papers, led statistical analysis activities involving multiple institutions, developed data management and statistical analysis plans for the clinical trials, ensured standardization of methods and the quality of the data by assessing and assisting study sites in the design and conduct of the study, mentored MSPH and PhD students, and taught a course on the spatial analysis of health events. Since beginning of 2020, I have working as a Biostatistics lead for pneumococcal franchise at the Pfizer VAC-Medical and involved in scientific data analysis of the various clinical studies around the globe. I am author or co-author of more than 200 publications and book chapters, reviewer of several peer-reviewed journals, Editor of PLoS ONE, and worked as a Research Consultant in several research institutes.

Speaker	Biography
Mohammad Ali	In 1984, I started my research career at the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B) focusing on data management and statistical analysis of a large clinical trial. Subsequently, I was involved in various studies on population and health at the Center. After completion of my Ph.D. in the field of spatial epidemiology, I joined at the International Vaccine Institute (IVI), Seoul, Korea as the Senior Scientist, and the Head of Biostatistics Unit in early 2001. I introduced Geographic Information System in vaccine evaluation studies for the various research sites of IVI. My spatial epidemiology studies investigated the effectiveness of cholera vaccines, the approach demonstrated that the use of geographic variations in vaccine coverage can help evaluate the indirect protective effects of the vaccine. This method is applicable to trials of a wide range of vaccines before they are introduced into public health practice. In addition, I used GIS, satellite remote sensing, and spatial modeling techniques in research that is grounded in geographic theories of human-environment interaction for generating hypotheses about potential causes of the health problems. I created model for the emergence and fluctuations of cholera by integrating spatial data sets including satellite imagery derived from different sensors, climatic variables, and socio-demographic characteristics (population distribution, and socio-economic status) of the people. In late 2013, I joined at the Johns Hopkins University as a Senior Scientist. At the university, I developed protocols and research studies, published scientific papers, led statistical analysis activities involving multiple institutions, developed data management and statistical analysis plans for the clinical trials, ensured standardization of methods and the quality of the data by assessing and assisting study sites in the design and conduct of the study, mentored MSPH and PhD students, and taught a course on the spatial analysis of health events. Since beginning of 2020, I have working as a Biostatistics lead for pneumococcal franchise at the Pfizer VAC-Medical and involved in scientific data analysis of the various clinical studies around the globe. I am author or co-author of more than 200 publications and book chapters, reviewer of several peer-reviewed journals, Editor of PLoS ONE, and worked as a Research Consultant in several research institutes.

Speaker	Biography
Mohammad Ali	In 1984, I started my research career at the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B) focusing on data management and statistical analysis of a large clinical trial. Subsequently, I was involved in various studies on population and health at the Center. After completion of my Ph.D. in the field of spatial epidemiology, I joined at the International Vaccine Institute (IVI), Seoul, Korea as the Senior Scientist, and the Head of Biostatistics Unit in early 2001. I introduced Geographic Information System in vaccine evaluation studies for the various research sites of IVI. My spatial epidemiology studies investigated the effectiveness of cholera vaccines, the approach demonstrated that the use of geographic variations in vaccine coverage can help evaluate the indirect protective effects of the vaccine. This method is applicable to trials of a wide range of vaccines before they are introduced into public health practice. In addition, I used GIS, satellite remote sensing, and spatial modeling techniques in research that is grounded in geographic theories of human-environment interaction for generating hypotheses about potential causes of the health problems. I created model for the emergence and fluctuations of cholera by integrating spatial data sets including satellite imagery derived from different sensors, climatic variables, and socio-demographic characteristics (population distribution, and socio-economic status) of the people. In late 2013, I joined at the Johns Hopkins University as a Senior Scientist. At the university, I developed protocols and research studies, published scientific papers, led statistical analysis activities involving multiple institutions, developed data management and statistical analysis plans for the clinical trials, ensured standardization of methods and the quality of the data by assessing and assisting study sites in the design and conduct of the study, mentored MSPH and PhD students, and taught a course on the spatial analysis of health events. Since beginning of 2020, I have working as a Biostatistics lead for pneumococcal franchise at the Pfizer VAC-Medical and involved in scientific data analysis of the various clinical studies around the globe. I am author or co-author of more than 200 publications and book chapters, reviewer of several peer-reviewed journals, Editor of PLoS ONE, and worked as a Research Consultant in several research institutes.

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