Date: Thursday 5th November 2020
Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST)
Speakers: John Scott (FDA), Andreas Brandt (BfArM), Vladimir Dragalin (JNJ) and Evgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia.
What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
|
Speaker |
Biography |
 John Scott |
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics. |
 Andreas Brandt |
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology. |
|
|
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research. |
|
|
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org). |
Date: Thursday 5th November 2020
Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST)
Speakers: John Scott (FDA), Andreas Brandt (BfArM), Vladimir Dragalin (JNJ) and Evgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia.
What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
|
Speaker |
Biography |
| John Scott |
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics. |
| Andreas Brandt |
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology. |
|
|
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research. |
|
|
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org). |
Date: Thursday 5th November 2020
Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST)
Speakers: John Scott (FDA), Andreas Brandt (BfArM), Vladimir Dragalin (JNJ) and Evgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia.
What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
|
Speaker |
Biography |
| John Scott |
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics. |
| Andreas Brandt |
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology. |
|
|
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research. |
|
|
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org). |
Date: Thursday 5th November 2020
Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST)
Speakers: John Scott (FDA), Andreas Brandt (BfArM), Vladimir Dragalin (JNJ) and Evgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia.
What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
|
Speaker |
Biography |
| John Scott |
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics. |
| Andreas Brandt |
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology. |
|
|
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research. |
|
|
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org). |
Date: Thursday 5th November 2020
Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST)
Speakers: John Scott (FDA), Andreas Brandt (BfArM), Vladimir Dragalin (JNJ) and Evgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia.
What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
|
Speaker |
Biography |
| John Scott |
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics. |
| Andreas Brandt |
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology. |
|
|
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research. |
|
|
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org). |
Date: Thursday 5th November 2020
Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST)
Speakers: John Scott (FDA), Andreas Brandt (BfArM), Vladimir Dragalin (JNJ) and Evgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia.
What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
|
Speaker |
Biography |
| John Scott |
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics. |
| Andreas Brandt |
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology. |
|
|
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research. |
|
|
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org). |
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.
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
Our monthly webinar will allow attendees to gain practical knowledge and skills in Open-Source coding and tools, with a focus on applications in the pharmaceutical industry. The sessions will provide starting points in a number of areas, correct any common misconceptions and provide valuable resources for further learning.
Date: Tuesday 9th September 2025 Join us to hear Sofia Weigle and Weng-Kee Wong present their recent work.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.
The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.
The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.
Four sessions will include ML foundation (including an introduction, data exploration for ML and dimensionality reduction and feature selection), Supervised learning (including support vector machines and model evaluation and interpretation), model optimization and unsupervised learning (including clustering) and advanced topics (including neural networks, deep learning and large language models).
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
Date: Wednesday 5th November 2025 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Date: 19 November 2025 This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
As an Associate Director Biostatistics Early Development, you will be a key member of our biostatistics group, you will play a crucial role in the design, analysis, and interpretation of clinical trials for early development programs.
If you are passionate about biostatistics and real-world data, and are looking for an exciting opportunity to contribute to groundbreaking research, we encourage you to apply.
Are you passionate about making a difference in the world of healthcare? Novartis is seeking a dynamic and experienced professional to join our team in London at The Westworks.
As the Director of HTA Biostatistics & Medical Affairs, you will play a pivotal role in shaping the future of healthcare by providing strategic biostatistical leadership and expertise.
An exciting opportunity has arisen for a permanent Senior Medical Statistician & Statistical Programmer to join the UKCRC fully registered Derby Clinical Trials Support Unit (Derby CTSU).
As a Senior Principal Biostatistician, you will be responsible and accountable for all statistical work, both scientific and operational, for one or more assigned clinical trials
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The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| AWSALBTGCORS | psi.glueup.com | Amazon Web Services, Inc. | 7 days |
Used by Target Group-based load balancers for session stickiness. | |||
| AWSALBCORS | psi.glueup.com | Amazon Web Services, Inc. | 7 days |
Maintains session stickiness and secure routing between the user and backend servers through AWS load balancing. | |||
| PHPSESSID | psi.glueup.com | Session | |
Cookie generated by applications based on the PHP language. This is a general purpose identifier used to maintain user session variables. It is normally a random generated number, how it is used can be specific to the site, but a good example is maintaining a logged-in status for a user between pages. | |||
| History.store | Session | ||
| cookiehub | .psiweb.org | CookieHub | 365 days |
Used by CookieHub to store information about whether visitors have given or declined the use of cookie categories used on the site. | |||
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| vuid | .vimeo.com | 400 days | |
These cookies are used by the Vimeo video player on websites. | |||
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| _ga_ | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics 4 to determine that two distinct hits belong to the same user across browsing sessions. | |||
| _ga | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics to determine that two distinct hits belong to the same user across browsing sessions. | |||
