Who is this event intended for? Statisticians/researchers working in vaccine, monoclonal antibody or infectious diseases. What is the benefit of attending? This webinar will help statisticians/researchers working in the vaccine and monoclonal antibody fields better understand each other's work and the potential synergies in collaborating with each other.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
Overview
The speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
Presentation Abstract
Catalysed by the rapid research and development of preventive and therapeutic monoclonal antibodies in multiple biomedical fields, there is an increasing demand of innovative statistical research in the design and analysis of monoclonal antibody studies. Published in 2022, a new biomarker, called PT80 was identified as a promising surrogate endpoint to reliably predict the ability of broadly neutralizing monoclonal antibodies to prevent acquisition of HIV-1. Findings from this study build on the proof-of-concept Antibody Mediated Prevention (AMP) trials showing that an mAb called VRC01 was effective in preventing the acquisition of some – but not all – HIV strains. In this talk, I will share our journey in reaching the discovery of PT80 for VRC01 via extending/innovating methodology and concepts from vaccine statistics to the design and analysis of monoclonal antibody studies.
Speaker details
Speaker
Biography
Dr. Yunda Huang
Dr. Huang’s research areas have focused on the statistical design and analysis of vaccine clinical trials, monoclonal antibody clinical trials and immunological biomarker studies related to the prevention and treatment of HIV and other infectious diseases. She has worked closely with academic, regulatory and industrial collaborators in providing statistical leadership for 20+ phase 1/2/2b pre-efficacy and efficacy trials, and on the immune correlates studies for several landmark HIV prevention and therapeutic efficacy trials. In recent years, she spearheaded fruitful collaborations in bridging the gap between statistical methodology and pharmacometric applications in the design and analysis of single and combination HIV monoclonal antibody trials. Dr. Huang has published 100+ scientific papers in both methodological and applied statistical journals, as well as in biomedical and pharmacokinetics journals.
Dr. Huang obtained her B.S. degree in Statistics from the Renmin University of China, and her Ph.D. degree in Biostatistics from the University of California, Los Angeles.
Scientific Meetings
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
Who is this event intended for? Statisticians/researchers working in vaccine, monoclonal antibody or infectious diseases. What is the benefit of attending? This webinar will help statisticians/researchers working in the vaccine and monoclonal antibody fields better understand each other's work and the potential synergies in collaborating with each other.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
Overview
The speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
Presentation Abstract
Catalysed by the rapid research and development of preventive and therapeutic monoclonal antibodies in multiple biomedical fields, there is an increasing demand of innovative statistical research in the design and analysis of monoclonal antibody studies. Published in 2022, a new biomarker, called PT80 was identified as a promising surrogate endpoint to reliably predict the ability of broadly neutralizing monoclonal antibodies to prevent acquisition of HIV-1. Findings from this study build on the proof-of-concept Antibody Mediated Prevention (AMP) trials showing that an mAb called VRC01 was effective in preventing the acquisition of some – but not all – HIV strains. In this talk, I will share our journey in reaching the discovery of PT80 for VRC01 via extending/innovating methodology and concepts from vaccine statistics to the design and analysis of monoclonal antibody studies.
Speaker details
Speaker
Biography
Dr. Yunda Huang
Dr. Huang’s research areas have focused on the statistical design and analysis of vaccine clinical trials, monoclonal antibody clinical trials and immunological biomarker studies related to the prevention and treatment of HIV and other infectious diseases. She has worked closely with academic, regulatory and industrial collaborators in providing statistical leadership for 20+ phase 1/2/2b pre-efficacy and efficacy trials, and on the immune correlates studies for several landmark HIV prevention and therapeutic efficacy trials. In recent years, she spearheaded fruitful collaborations in bridging the gap between statistical methodology and pharmacometric applications in the design and analysis of single and combination HIV monoclonal antibody trials. Dr. Huang has published 100+ scientific papers in both methodological and applied statistical journals, as well as in biomedical and pharmacokinetics journals.
Dr. Huang obtained her B.S. degree in Statistics from the Renmin University of China, and her Ph.D. degree in Biostatistics from the University of California, Los Angeles.
Training Courses
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
Who is this event intended for? Statisticians/researchers working in vaccine, monoclonal antibody or infectious diseases. What is the benefit of attending? This webinar will help statisticians/researchers working in the vaccine and monoclonal antibody fields better understand each other's work and the potential synergies in collaborating with each other.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
Overview
The speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
Presentation Abstract
Catalysed by the rapid research and development of preventive and therapeutic monoclonal antibodies in multiple biomedical fields, there is an increasing demand of innovative statistical research in the design and analysis of monoclonal antibody studies. Published in 2022, a new biomarker, called PT80 was identified as a promising surrogate endpoint to reliably predict the ability of broadly neutralizing monoclonal antibodies to prevent acquisition of HIV-1. Findings from this study build on the proof-of-concept Antibody Mediated Prevention (AMP) trials showing that an mAb called VRC01 was effective in preventing the acquisition of some – but not all – HIV strains. In this talk, I will share our journey in reaching the discovery of PT80 for VRC01 via extending/innovating methodology and concepts from vaccine statistics to the design and analysis of monoclonal antibody studies.
Speaker details
Speaker
Biography
Dr. Yunda Huang
Dr. Huang’s research areas have focused on the statistical design and analysis of vaccine clinical trials, monoclonal antibody clinical trials and immunological biomarker studies related to the prevention and treatment of HIV and other infectious diseases. She has worked closely with academic, regulatory and industrial collaborators in providing statistical leadership for 20+ phase 1/2/2b pre-efficacy and efficacy trials, and on the immune correlates studies for several landmark HIV prevention and therapeutic efficacy trials. In recent years, she spearheaded fruitful collaborations in bridging the gap between statistical methodology and pharmacometric applications in the design and analysis of single and combination HIV monoclonal antibody trials. Dr. Huang has published 100+ scientific papers in both methodological and applied statistical journals, as well as in biomedical and pharmacokinetics journals.
Dr. Huang obtained her B.S. degree in Statistics from the Renmin University of China, and her Ph.D. degree in Biostatistics from the University of California, Los Angeles.
Journal Club
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
Who is this event intended for? Statisticians/researchers working in vaccine, monoclonal antibody or infectious diseases. What is the benefit of attending? This webinar will help statisticians/researchers working in the vaccine and monoclonal antibody fields better understand each other's work and the potential synergies in collaborating with each other.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
Overview
The speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
Presentation Abstract
Catalysed by the rapid research and development of preventive and therapeutic monoclonal antibodies in multiple biomedical fields, there is an increasing demand of innovative statistical research in the design and analysis of monoclonal antibody studies. Published in 2022, a new biomarker, called PT80 was identified as a promising surrogate endpoint to reliably predict the ability of broadly neutralizing monoclonal antibodies to prevent acquisition of HIV-1. Findings from this study build on the proof-of-concept Antibody Mediated Prevention (AMP) trials showing that an mAb called VRC01 was effective in preventing the acquisition of some – but not all – HIV strains. In this talk, I will share our journey in reaching the discovery of PT80 for VRC01 via extending/innovating methodology and concepts from vaccine statistics to the design and analysis of monoclonal antibody studies.
Speaker details
Speaker
Biography
Dr. Yunda Huang
Dr. Huang’s research areas have focused on the statistical design and analysis of vaccine clinical trials, monoclonal antibody clinical trials and immunological biomarker studies related to the prevention and treatment of HIV and other infectious diseases. She has worked closely with academic, regulatory and industrial collaborators in providing statistical leadership for 20+ phase 1/2/2b pre-efficacy and efficacy trials, and on the immune correlates studies for several landmark HIV prevention and therapeutic efficacy trials. In recent years, she spearheaded fruitful collaborations in bridging the gap between statistical methodology and pharmacometric applications in the design and analysis of single and combination HIV monoclonal antibody trials. Dr. Huang has published 100+ scientific papers in both methodological and applied statistical journals, as well as in biomedical and pharmacokinetics journals.
Dr. Huang obtained her B.S. degree in Statistics from the Renmin University of China, and her Ph.D. degree in Biostatistics from the University of California, Los Angeles.
Webinars
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
Who is this event intended for? Statisticians/researchers working in vaccine, monoclonal antibody or infectious diseases. What is the benefit of attending? This webinar will help statisticians/researchers working in the vaccine and monoclonal antibody fields better understand each other's work and the potential synergies in collaborating with each other.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
Overview
The speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
Presentation Abstract
Catalysed by the rapid research and development of preventive and therapeutic monoclonal antibodies in multiple biomedical fields, there is an increasing demand of innovative statistical research in the design and analysis of monoclonal antibody studies. Published in 2022, a new biomarker, called PT80 was identified as a promising surrogate endpoint to reliably predict the ability of broadly neutralizing monoclonal antibodies to prevent acquisition of HIV-1. Findings from this study build on the proof-of-concept Antibody Mediated Prevention (AMP) trials showing that an mAb called VRC01 was effective in preventing the acquisition of some – but not all – HIV strains. In this talk, I will share our journey in reaching the discovery of PT80 for VRC01 via extending/innovating methodology and concepts from vaccine statistics to the design and analysis of monoclonal antibody studies.
Speaker details
Speaker
Biography
Dr. Yunda Huang
Dr. Huang’s research areas have focused on the statistical design and analysis of vaccine clinical trials, monoclonal antibody clinical trials and immunological biomarker studies related to the prevention and treatment of HIV and other infectious diseases. She has worked closely with academic, regulatory and industrial collaborators in providing statistical leadership for 20+ phase 1/2/2b pre-efficacy and efficacy trials, and on the immune correlates studies for several landmark HIV prevention and therapeutic efficacy trials. In recent years, she spearheaded fruitful collaborations in bridging the gap between statistical methodology and pharmacometric applications in the design and analysis of single and combination HIV monoclonal antibody trials. Dr. Huang has published 100+ scientific papers in both methodological and applied statistical journals, as well as in biomedical and pharmacokinetics journals.
Dr. Huang obtained her B.S. degree in Statistics from the Renmin University of China, and her Ph.D. degree in Biostatistics from the University of California, Los Angeles.
Careers Meetings
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
Who is this event intended for? Statisticians/researchers working in vaccine, monoclonal antibody or infectious diseases. What is the benefit of attending? This webinar will help statisticians/researchers working in the vaccine and monoclonal antibody fields better understand each other's work and the potential synergies in collaborating with each other.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
Overview
The speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
Presentation Abstract
Catalysed by the rapid research and development of preventive and therapeutic monoclonal antibodies in multiple biomedical fields, there is an increasing demand of innovative statistical research in the design and analysis of monoclonal antibody studies. Published in 2022, a new biomarker, called PT80 was identified as a promising surrogate endpoint to reliably predict the ability of broadly neutralizing monoclonal antibodies to prevent acquisition of HIV-1. Findings from this study build on the proof-of-concept Antibody Mediated Prevention (AMP) trials showing that an mAb called VRC01 was effective in preventing the acquisition of some – but not all – HIV strains. In this talk, I will share our journey in reaching the discovery of PT80 for VRC01 via extending/innovating methodology and concepts from vaccine statistics to the design and analysis of monoclonal antibody studies.
Speaker details
Speaker
Biography
Dr. Yunda Huang
Dr. Huang’s research areas have focused on the statistical design and analysis of vaccine clinical trials, monoclonal antibody clinical trials and immunological biomarker studies related to the prevention and treatment of HIV and other infectious diseases. She has worked closely with academic, regulatory and industrial collaborators in providing statistical leadership for 20+ phase 1/2/2b pre-efficacy and efficacy trials, and on the immune correlates studies for several landmark HIV prevention and therapeutic efficacy trials. In recent years, she spearheaded fruitful collaborations in bridging the gap between statistical methodology and pharmacometric applications in the design and analysis of single and combination HIV monoclonal antibody trials. Dr. Huang has published 100+ scientific papers in both methodological and applied statistical journals, as well as in biomedical and pharmacokinetics journals.
Dr. Huang obtained her B.S. degree in Statistics from the Renmin University of China, and her Ph.D. degree in Biostatistics from the University of California, Los Angeles.
Upcoming Events
PSI Book Club: Change: How organisations achieve hard-to-imagine results in uncertain and volatile times
Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change.
Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization.
Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.
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 Training Course: Propensity Scores: Practical Application in Non-randomised Studies
The course will introduce the topic of propensity scores and the use of external data. Covering the topics of matching and weighting as well as more advance topics of high dimension propensity scores, multi-valued treatments, double robustness and time-varying scenarios. There will be the opportunity to participate in some hands on practical exercises in R.
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.
Making Estimands Work - Practical Approaches with Implementation in Data Standards
This event will discuss the impact of the estimand framework on data flow and data handling for analysis datasets (ADaM). What are the considerations to produce data sets suitable for estimation of estimands and traceability of the occurrence of intercurrent events. This webinar will include tips for best practice, based on the White paper Implementation of ICH E9(R1) Estimands Framework using Data Standards.
PSI/EFSPI Biomarker SIG Webinar: Statistical Methods for ctDNA Data
This webinar will describe what ctDNA is and what the key challenges are for analysing it. We will then summarise and review methods that were published over the last few years for analysing ctDNA data.
The morning will be dedicated to networking opportunities, helping attendees build connections with peers and professionals. In the afternoon, participants can attend a series of talks and workshops, including a career panel featuring speakers from both academia and industry, offering insights into various career paths. There will also be a statistical workshop, as well as the opportunity to learn about and debate some of the hot topics in the world of medical statistics. To wrap up the day, we’re exploring interest in an informal after-work networking event for those keen to continue the conversation.
Joint PSI/EFSPI, Phuse, ASA Safety Working Group Webinar Series: Overview of safety analysis and implementation process of safety surveillance in ongoing studies
The session will have three speakers and a discussant. This session will be the first in a series of webinars around safety in clinical trials. The series is co-organized by PSI, ASA-Biopharm safety working group and PHUSE.
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
PSI Vaccines SIG Webinar: Statistical Immune Correlate Analysis of Hemagglutination Inhibition Titers for an mRNA-based Influenza Vaccine
This 1-hour webinar is designed for statisticians with an interest in vaccine development, to learn about the recent application of statistical immune correlate analysis in vaccine development. Specifically, an application of such analyses to evaluate hemagglutination inhibition titers for an influenza vaccine
PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics
Date: Wednesday 4th November 2026
A careers talk about medical statistics and how it plays a crucial role in developing new medicines. Learn about the field of medical statistics and how it plays a crucial role in developing groundbreaking new medicines, vaccines and healthcare products.
Date: 18 November 2026
This is an excellent opportunity for students to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future. All students currently studying for a mathematics or statistics-related BSc, MSc or PhD are invited to attend, and we welcome interest from exhibitors too.
Aligning Estimation with the Clinical Question of Interest
This webinar will focus on aligning estimation to estimands. How do different strategies for handling intercurrent events and missing data handling influence the choice of estimation method, with illustration using a case study.
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 Careers Coaching Series: Peer Support Initiative
This 10-month peer support programme is aimed at professionals with five or more years of experience who are seeking structured development and connection with peers at a similar career stage. Through 5 bi-monthly topics, participants will engage in coach-led presentations, small-group discussions, and regular progress reviews focused on achieving tangible outcomes.
In this vital role you will generate evidence to meet Health Technology Assessment (HTA) requirements, while ensuring that the analyses performed meet required standards and are robust and valid.
Bristol Myers Squibb - Director, Statistical Methodology and Innovation
Lead the development of innovative statistical methods, provides expert consulting, oversees tools and software, and mentors team members while collaborating cross-functionally to address complex drug development challenges.
Phastar – Associate Director, Statistics – Real World Evidence (RWE)
As an Associate Director, Statistics (RWE) you will focus on supporting one of our key pharmaceutical clients within our FSP function. This will be a hands-on technical role, with oversight responsibilities and cross-functional exposure.
Phastar – Principal Statistician – Real World Evidence (RWE)
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at Principal level.
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at either Senior or Principal levels.
This position is deal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.
