PSI Webinar: Discover Data Science

PSI Mentoring 2025

Date: Ongoing 6 month cycle beginning late April/early May 2024 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.

PSI Training Course: Mixed Models and Repeated Measures

This course is presented through lectures and practical sessions using SAS code. It is suitable for statisticians working on clinical trials, who already have a good understanding of linear and generalised linear models.

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 Career Young Virtual Event (Q1 2025)

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 Estimand Online Training (4 Day Workshop)

This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.

Maths Meets Medicine: Exploring Careers in the Pharmaceutical Industry

This session will showcase how careers in pharmaceutical statistics can be both rewarding and impactful, with a focus on how mathematics is integral to the development of medicines. Students will hear from industry experts, explore diverse career paths, and learn why continuing to study math is key to unlocking exciting opportunities in the healthcare sector.

Dissolution Testing: Time for Statistical (r)Evolution

Webinar dedicated to the topic of dissolution of oral solid dosage forms; opportunity to hear from statisticians working in the CMC field, with open question and answers. In addition, the CMC Statistical Network Europe special interest group will discuss advocacy opportunities, have your say to contribute to the future direction.

PSI Career Young Virtual Event (Q2 2025)

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 Career Young Virtual Event (Q3 2025)

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 Career Young Virtual Event (Q4 2025)

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	Abstract
Carsten Henneges	Carsten Henneges studied bioinformatics with main at molecular biology at the Eberhard-Karls University of Tübingen. He received a PhD in computer science for research in applied machine learning and data mining in Proteomics and Metabolomics. He then worked for 8 years at Eli Lilly as project statistician supporting late phase trials and analyses across multiple therapeutic areas. He received the certificate for Biometry in Medicine from the GMDS in 2017. After a short period working for the Comprehensive Heart Failure Center in Würzburg and supporting the Early Phase Immuno-Oncology team at Genentech, he is employed by Sanofi at the mRNA center of excellence. Currently he has been an active member of the PSI Data Science SIG since its initiation in 2019.	How much and where is Software Development needed to be successful in Drug Development? As Data fuels this Industry, it is inevitably a part of it. This presentation will try to shed some light onto the role and needs of Data Scientists in Pharma.
Munshi Imran Hossain	Munshi Imran Hossain is a Senior Research Consultant at the Therapeutic Development Group at Cytel. He is a trained Biomedical engineer. Imran has over 10 years of experience in the design and analysis of adaptive trials. He has also been involved in working on data science problems. He has worked on biomarker signatures for enrichment trials, analysis of wearables data for device trials, analysis of multi-array gene expression data, among others. Imran is also a member of the R Validation Hub where he is working on the risk assessment of R packages.	Data science in healthcare has seen rapid growth because of the availability of large amounts of data of various kinds. Today, companies have access to real-time data from mobile phones and wearable devices. They have access to gene expression data as well as many different biomarkers. As part of the consulting group, we are fortunate to have the opportunity to work on different kinds of problems. One of the most common problems that we encounter is the discovery of biomarker signatures that companies want to use for enrichment studies. We've also seen other interesting problems such as signal alignment and reliability when there is data from multiple sources. Another important, although oft-neglected, aspect is the reproducibility and explainability of results. Healthcare is highly regulated; the preference is for models whose inner workings can be easily explained. The reproducibility of results is another challenge. This requires mature data and workflow pipelines that allow for accessing and processing large quantities of data in a reproducible environment. In this talk, I would like to reflect on some of the challenging problems and the challenges faced during the building of the solution.
Prof. Keith Abrams	Keith Abrams is Professor of Statistics & Data Science in the Department of Statistics at the University of Warwick and a National Institute for Health Research (NIHR) Senior Investigator Emeritus. He is also Honorary Professor in the Centre for Health Economics at the University of York. His research centres around the development, evaluation, and application of (Bayesian) statistical methods in Health Technology Assessment (HTA) and Health Data Science, and is supported by EU/UKRI, Health Data Research (HDR) UK, Medical Research Council (MRC), National Institute for Health & care Research (NIHR) and industry. Prof Abrams has been extensively involved with the UK National Institute for Health & Care Excellence (NICE) since its inception. He was a member of the NICE Technology Appraisals Committee for over 8 years, and is currently a member of the NICE Diagnostics Advisory Committee, NICE Decision Support Unit (DSU) and NICE Technical Support Unit (TSU). He is a Fellow of the Royal Statistical Society, and a Chartered Statistician. He has published widely in both substantive and methodological areas including co-authoring books on Methods for Meta-Analysis in Medical Research, Bayesian Approaches to Clinical Trials and Healthcare Evaluation, and Evidence Synthesis for Decision Making in Healthcare, in addition to co-editing a text on Methods for Evidence-based Healthcare. Prof Abrams has extensive experience over the last 25 years as a consultant to the pharmaceutical and life sciences sectors, providing both methodological and strategic HTA advice across a wide range of therapeutic areas, as well as internationally to non-UK governments and reimbursement/HTA agencies. He is also a founding partner and director of Visible Analytics Limited – an international HTA consultancy company headquartered in Oxford, UK.	The current explosion in data availability raises a number of issues and challenges as regards how they should be analysed. In this talk I will touch on a number of these including; issues with linked Electronic Health Record [EHR] data (including problems with ignoring data generating mechanisms), increasing access to individual study data & use of federated analyses, the explosion in data-driven health technologies (producing high-dimensional, high frequency data and the need to link such data to clinical/process outcomes), and how agencies such as NICE, in England & Wales, evaluate such technologies to inform health policy.

Speaker	Biography	Abstract
Carsten Henneges	Carsten Henneges studied bioinformatics with main at molecular biology at the Eberhard-Karls University of Tübingen. He received a PhD in computer science for research in applied machine learning and data mining in Proteomics and Metabolomics. He then worked for 8 years at Eli Lilly as project statistician supporting late phase trials and analyses across multiple therapeutic areas. He received the certificate for Biometry in Medicine from the GMDS in 2017. After a short period working for the Comprehensive Heart Failure Center in Würzburg and supporting the Early Phase Immuno-Oncology team at Genentech, he is employed by Sanofi at the mRNA center of excellence. Currently he has been an active member of the PSI Data Science SIG since its initiation in 2019.	How much and where is Software Development needed to be successful in Drug Development? As Data fuels this Industry, it is inevitably a part of it. This presentation will try to shed some light onto the role and needs of Data Scientists in Pharma.
Munshi Imran Hossain	Munshi Imran Hossain is a Senior Research Consultant at the Therapeutic Development Group at Cytel. He is a trained Biomedical engineer. Imran has over 10 years of experience in the design and analysis of adaptive trials. He has also been involved in working on data science problems. He has worked on biomarker signatures for enrichment trials, analysis of wearables data for device trials, analysis of multi-array gene expression data, among others. Imran is also a member of the R Validation Hub where he is working on the risk assessment of R packages.	Data science in healthcare has seen rapid growth because of the availability of large amounts of data of various kinds. Today, companies have access to real-time data from mobile phones and wearable devices. They have access to gene expression data as well as many different biomarkers. As part of the consulting group, we are fortunate to have the opportunity to work on different kinds of problems. One of the most common problems that we encounter is the discovery of biomarker signatures that companies want to use for enrichment studies. We've also seen other interesting problems such as signal alignment and reliability when there is data from multiple sources. Another important, although oft-neglected, aspect is the reproducibility and explainability of results. Healthcare is highly regulated; the preference is for models whose inner workings can be easily explained. The reproducibility of results is another challenge. This requires mature data and workflow pipelines that allow for accessing and processing large quantities of data in a reproducible environment. In this talk, I would like to reflect on some of the challenging problems and the challenges faced during the building of the solution.
Prof. Keith Abrams	Keith Abrams is Professor of Statistics & Data Science in the Department of Statistics at the University of Warwick and a National Institute for Health Research (NIHR) Senior Investigator Emeritus. He is also Honorary Professor in the Centre for Health Economics at the University of York. His research centres around the development, evaluation, and application of (Bayesian) statistical methods in Health Technology Assessment (HTA) and Health Data Science, and is supported by EU/UKRI, Health Data Research (HDR) UK, Medical Research Council (MRC), National Institute for Health & care Research (NIHR) and industry. Prof Abrams has been extensively involved with the UK National Institute for Health & Care Excellence (NICE) since its inception. He was a member of the NICE Technology Appraisals Committee for over 8 years, and is currently a member of the NICE Diagnostics Advisory Committee, NICE Decision Support Unit (DSU) and NICE Technical Support Unit (TSU). He is a Fellow of the Royal Statistical Society, and a Chartered Statistician. He has published widely in both substantive and methodological areas including co-authoring books on Methods for Meta-Analysis in Medical Research, Bayesian Approaches to Clinical Trials and Healthcare Evaluation, and Evidence Synthesis for Decision Making in Healthcare, in addition to co-editing a text on Methods for Evidence-based Healthcare. Prof Abrams has extensive experience over the last 25 years as a consultant to the pharmaceutical and life sciences sectors, providing both methodological and strategic HTA advice across a wide range of therapeutic areas, as well as internationally to non-UK governments and reimbursement/HTA agencies. He is also a founding partner and director of Visible Analytics Limited – an international HTA consultancy company headquartered in Oxford, UK.	The current explosion in data availability raises a number of issues and challenges as regards how they should be analysed. In this talk I will touch on a number of these including; issues with linked Electronic Health Record [EHR] data (including problems with ignoring data generating mechanisms), increasing access to individual study data & use of federated analyses, the explosion in data-driven health technologies (producing high-dimensional, high frequency data and the need to link such data to clinical/process outcomes), and how agencies such as NICE, in England & Wales, evaluate such technologies to inform health policy.

Speaker	Biography	Abstract
Carsten Henneges	Carsten Henneges studied bioinformatics with main at molecular biology at the Eberhard-Karls University of Tübingen. He received a PhD in computer science for research in applied machine learning and data mining in Proteomics and Metabolomics. He then worked for 8 years at Eli Lilly as project statistician supporting late phase trials and analyses across multiple therapeutic areas. He received the certificate for Biometry in Medicine from the GMDS in 2017. After a short period working for the Comprehensive Heart Failure Center in Würzburg and supporting the Early Phase Immuno-Oncology team at Genentech, he is employed by Sanofi at the mRNA center of excellence. Currently he has been an active member of the PSI Data Science SIG since its initiation in 2019.	How much and where is Software Development needed to be successful in Drug Development? As Data fuels this Industry, it is inevitably a part of it. This presentation will try to shed some light onto the role and needs of Data Scientists in Pharma.
Munshi Imran Hossain	Munshi Imran Hossain is a Senior Research Consultant at the Therapeutic Development Group at Cytel. He is a trained Biomedical engineer. Imran has over 10 years of experience in the design and analysis of adaptive trials. He has also been involved in working on data science problems. He has worked on biomarker signatures for enrichment trials, analysis of wearables data for device trials, analysis of multi-array gene expression data, among others. Imran is also a member of the R Validation Hub where he is working on the risk assessment of R packages.	Data science in healthcare has seen rapid growth because of the availability of large amounts of data of various kinds. Today, companies have access to real-time data from mobile phones and wearable devices. They have access to gene expression data as well as many different biomarkers. As part of the consulting group, we are fortunate to have the opportunity to work on different kinds of problems. One of the most common problems that we encounter is the discovery of biomarker signatures that companies want to use for enrichment studies. We've also seen other interesting problems such as signal alignment and reliability when there is data from multiple sources. Another important, although oft-neglected, aspect is the reproducibility and explainability of results. Healthcare is highly regulated; the preference is for models whose inner workings can be easily explained. The reproducibility of results is another challenge. This requires mature data and workflow pipelines that allow for accessing and processing large quantities of data in a reproducible environment. In this talk, I would like to reflect on some of the challenging problems and the challenges faced during the building of the solution.
Prof. Keith Abrams	Keith Abrams is Professor of Statistics & Data Science in the Department of Statistics at the University of Warwick and a National Institute for Health Research (NIHR) Senior Investigator Emeritus. He is also Honorary Professor in the Centre for Health Economics at the University of York. His research centres around the development, evaluation, and application of (Bayesian) statistical methods in Health Technology Assessment (HTA) and Health Data Science, and is supported by EU/UKRI, Health Data Research (HDR) UK, Medical Research Council (MRC), National Institute for Health & care Research (NIHR) and industry. Prof Abrams has been extensively involved with the UK National Institute for Health & Care Excellence (NICE) since its inception. He was a member of the NICE Technology Appraisals Committee for over 8 years, and is currently a member of the NICE Diagnostics Advisory Committee, NICE Decision Support Unit (DSU) and NICE Technical Support Unit (TSU). He is a Fellow of the Royal Statistical Society, and a Chartered Statistician. He has published widely in both substantive and methodological areas including co-authoring books on Methods for Meta-Analysis in Medical Research, Bayesian Approaches to Clinical Trials and Healthcare Evaluation, and Evidence Synthesis for Decision Making in Healthcare, in addition to co-editing a text on Methods for Evidence-based Healthcare. Prof Abrams has extensive experience over the last 25 years as a consultant to the pharmaceutical and life sciences sectors, providing both methodological and strategic HTA advice across a wide range of therapeutic areas, as well as internationally to non-UK governments and reimbursement/HTA agencies. He is also a founding partner and director of Visible Analytics Limited – an international HTA consultancy company headquartered in Oxford, UK.	The current explosion in data availability raises a number of issues and challenges as regards how they should be analysed. In this talk I will touch on a number of these including; issues with linked Electronic Health Record [EHR] data (including problems with ignoring data generating mechanisms), increasing access to individual study data & use of federated analyses, the explosion in data-driven health technologies (producing high-dimensional, high frequency data and the need to link such data to clinical/process outcomes), and how agencies such as NICE, in England & Wales, evaluate such technologies to inform health policy.

Speaker	Biography	Abstract
Carsten Henneges	Carsten Henneges studied bioinformatics with main at molecular biology at the Eberhard-Karls University of Tübingen. He received a PhD in computer science for research in applied machine learning and data mining in Proteomics and Metabolomics. He then worked for 8 years at Eli Lilly as project statistician supporting late phase trials and analyses across multiple therapeutic areas. He received the certificate for Biometry in Medicine from the GMDS in 2017. After a short period working for the Comprehensive Heart Failure Center in Würzburg and supporting the Early Phase Immuno-Oncology team at Genentech, he is employed by Sanofi at the mRNA center of excellence. Currently he has been an active member of the PSI Data Science SIG since its initiation in 2019.	How much and where is Software Development needed to be successful in Drug Development? As Data fuels this Industry, it is inevitably a part of it. This presentation will try to shed some light onto the role and needs of Data Scientists in Pharma.
Munshi Imran Hossain	Munshi Imran Hossain is a Senior Research Consultant at the Therapeutic Development Group at Cytel. He is a trained Biomedical engineer. Imran has over 10 years of experience in the design and analysis of adaptive trials. He has also been involved in working on data science problems. He has worked on biomarker signatures for enrichment trials, analysis of wearables data for device trials, analysis of multi-array gene expression data, among others. Imran is also a member of the R Validation Hub where he is working on the risk assessment of R packages.	Data science in healthcare has seen rapid growth because of the availability of large amounts of data of various kinds. Today, companies have access to real-time data from mobile phones and wearable devices. They have access to gene expression data as well as many different biomarkers. As part of the consulting group, we are fortunate to have the opportunity to work on different kinds of problems. One of the most common problems that we encounter is the discovery of biomarker signatures that companies want to use for enrichment studies. We've also seen other interesting problems such as signal alignment and reliability when there is data from multiple sources. Another important, although oft-neglected, aspect is the reproducibility and explainability of results. Healthcare is highly regulated; the preference is for models whose inner workings can be easily explained. The reproducibility of results is another challenge. This requires mature data and workflow pipelines that allow for accessing and processing large quantities of data in a reproducible environment. In this talk, I would like to reflect on some of the challenging problems and the challenges faced during the building of the solution.
Prof. Keith Abrams	Keith Abrams is Professor of Statistics & Data Science in the Department of Statistics at the University of Warwick and a National Institute for Health Research (NIHR) Senior Investigator Emeritus. He is also Honorary Professor in the Centre for Health Economics at the University of York. His research centres around the development, evaluation, and application of (Bayesian) statistical methods in Health Technology Assessment (HTA) and Health Data Science, and is supported by EU/UKRI, Health Data Research (HDR) UK, Medical Research Council (MRC), National Institute for Health & care Research (NIHR) and industry. Prof Abrams has been extensively involved with the UK National Institute for Health & Care Excellence (NICE) since its inception. He was a member of the NICE Technology Appraisals Committee for over 8 years, and is currently a member of the NICE Diagnostics Advisory Committee, NICE Decision Support Unit (DSU) and NICE Technical Support Unit (TSU). He is a Fellow of the Royal Statistical Society, and a Chartered Statistician. He has published widely in both substantive and methodological areas including co-authoring books on Methods for Meta-Analysis in Medical Research, Bayesian Approaches to Clinical Trials and Healthcare Evaluation, and Evidence Synthesis for Decision Making in Healthcare, in addition to co-editing a text on Methods for Evidence-based Healthcare. Prof Abrams has extensive experience over the last 25 years as a consultant to the pharmaceutical and life sciences sectors, providing both methodological and strategic HTA advice across a wide range of therapeutic areas, as well as internationally to non-UK governments and reimbursement/HTA agencies. He is also a founding partner and director of Visible Analytics Limited – an international HTA consultancy company headquartered in Oxford, UK.	The current explosion in data availability raises a number of issues and challenges as regards how they should be analysed. In this talk I will touch on a number of these including; issues with linked Electronic Health Record [EHR] data (including problems with ignoring data generating mechanisms), increasing access to individual study data & use of federated analyses, the explosion in data-driven health technologies (producing high-dimensional, high frequency data and the need to link such data to clinical/process outcomes), and how agencies such as NICE, in England & Wales, evaluate such technologies to inform health policy.

Speaker	Biography	Abstract
Carsten Henneges	Carsten Henneges studied bioinformatics with main at molecular biology at the Eberhard-Karls University of Tübingen. He received a PhD in computer science for research in applied machine learning and data mining in Proteomics and Metabolomics. He then worked for 8 years at Eli Lilly as project statistician supporting late phase trials and analyses across multiple therapeutic areas. He received the certificate for Biometry in Medicine from the GMDS in 2017. After a short period working for the Comprehensive Heart Failure Center in Würzburg and supporting the Early Phase Immuno-Oncology team at Genentech, he is employed by Sanofi at the mRNA center of excellence. Currently he has been an active member of the PSI Data Science SIG since its initiation in 2019.	How much and where is Software Development needed to be successful in Drug Development? As Data fuels this Industry, it is inevitably a part of it. This presentation will try to shed some light onto the role and needs of Data Scientists in Pharma.
Munshi Imran Hossain	Munshi Imran Hossain is a Senior Research Consultant at the Therapeutic Development Group at Cytel. He is a trained Biomedical engineer. Imran has over 10 years of experience in the design and analysis of adaptive trials. He has also been involved in working on data science problems. He has worked on biomarker signatures for enrichment trials, analysis of wearables data for device trials, analysis of multi-array gene expression data, among others. Imran is also a member of the R Validation Hub where he is working on the risk assessment of R packages.	Data science in healthcare has seen rapid growth because of the availability of large amounts of data of various kinds. Today, companies have access to real-time data from mobile phones and wearable devices. They have access to gene expression data as well as many different biomarkers. As part of the consulting group, we are fortunate to have the opportunity to work on different kinds of problems. One of the most common problems that we encounter is the discovery of biomarker signatures that companies want to use for enrichment studies. We've also seen other interesting problems such as signal alignment and reliability when there is data from multiple sources. Another important, although oft-neglected, aspect is the reproducibility and explainability of results. Healthcare is highly regulated; the preference is for models whose inner workings can be easily explained. The reproducibility of results is another challenge. This requires mature data and workflow pipelines that allow for accessing and processing large quantities of data in a reproducible environment. In this talk, I would like to reflect on some of the challenging problems and the challenges faced during the building of the solution.
Prof. Keith Abrams	Keith Abrams is Professor of Statistics & Data Science in the Department of Statistics at the University of Warwick and a National Institute for Health Research (NIHR) Senior Investigator Emeritus. He is also Honorary Professor in the Centre for Health Economics at the University of York. His research centres around the development, evaluation, and application of (Bayesian) statistical methods in Health Technology Assessment (HTA) and Health Data Science, and is supported by EU/UKRI, Health Data Research (HDR) UK, Medical Research Council (MRC), National Institute for Health & care Research (NIHR) and industry. Prof Abrams has been extensively involved with the UK National Institute for Health & Care Excellence (NICE) since its inception. He was a member of the NICE Technology Appraisals Committee for over 8 years, and is currently a member of the NICE Diagnostics Advisory Committee, NICE Decision Support Unit (DSU) and NICE Technical Support Unit (TSU). He is a Fellow of the Royal Statistical Society, and a Chartered Statistician. He has published widely in both substantive and methodological areas including co-authoring books on Methods for Meta-Analysis in Medical Research, Bayesian Approaches to Clinical Trials and Healthcare Evaluation, and Evidence Synthesis for Decision Making in Healthcare, in addition to co-editing a text on Methods for Evidence-based Healthcare. Prof Abrams has extensive experience over the last 25 years as a consultant to the pharmaceutical and life sciences sectors, providing both methodological and strategic HTA advice across a wide range of therapeutic areas, as well as internationally to non-UK governments and reimbursement/HTA agencies. He is also a founding partner and director of Visible Analytics Limited – an international HTA consultancy company headquartered in Oxford, UK.	The current explosion in data availability raises a number of issues and challenges as regards how they should be analysed. In this talk I will touch on a number of these including; issues with linked Electronic Health Record [EHR] data (including problems with ignoring data generating mechanisms), increasing access to individual study data & use of federated analyses, the explosion in data-driven health technologies (producing high-dimensional, high frequency data and the need to link such data to clinical/process outcomes), and how agencies such as NICE, in England & Wales, evaluate such technologies to inform health policy.

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