Past PSI Events

Conferences

Structured Benefit–Risk Assessment Webinar

Please join our webinar. We'll have 2 presentations from widely known speakers:

The emerging and merging fields of benefit-risk and health technology assessments

by Jason (Jixian Wang), Shahrul Mt-Isa and Susan Talbot, on behalf of the EFSPI BRA/HTA joint working group

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

by George Quartey

The webinar occurs twice - please register for one of the following dates:
  • 1st webinar: 2017 February 9, 5pm CET (4pm GMT)
  • 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)
Click here to view the flyer!

 Here is some further background information about the content and the presenters:

The emerging and merging fields of benefit-risk and health technology assessments

jason
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies. About the presenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.  

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

georg
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation. About the presenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.

To access the recording, please visit the Video-on-Demand Library.

Scientific Meetings

Structured Benefit–Risk Assessment Webinar

Please join our webinar. We'll have 2 presentations from widely known speakers:

The emerging and merging fields of benefit-risk and health technology assessments

by Jason (Jixian Wang), Shahrul Mt-Isa and Susan Talbot, on behalf of the EFSPI BRA/HTA joint working group

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

by George Quartey

The webinar occurs twice - please register for one of the following dates:
  • 1st webinar: 2017 February 9, 5pm CET (4pm GMT)
  • 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)
Click here to view the flyer!

 Here is some further background information about the content and the presenters:

The emerging and merging fields of benefit-risk and health technology assessments

jason
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies. About the presenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.  

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

georg
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation. About the presenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.

To access the recording, please visit the Video-on-Demand Library.

Training Courses

Structured Benefit–Risk Assessment Webinar

Please join our webinar. We'll have 2 presentations from widely known speakers:

The emerging and merging fields of benefit-risk and health technology assessments

by Jason (Jixian Wang), Shahrul Mt-Isa and Susan Talbot, on behalf of the EFSPI BRA/HTA joint working group

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

by George Quartey

The webinar occurs twice - please register for one of the following dates:
  • 1st webinar: 2017 February 9, 5pm CET (4pm GMT)
  • 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)
Click here to view the flyer!

 Here is some further background information about the content and the presenters:

The emerging and merging fields of benefit-risk and health technology assessments

jason
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies. About the presenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.  

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

georg
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation. About the presenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.

To access the recording, please visit the Video-on-Demand Library.

Journal Club

Structured Benefit–Risk Assessment Webinar

Please join our webinar. We'll have 2 presentations from widely known speakers:

The emerging and merging fields of benefit-risk and health technology assessments

by Jason (Jixian Wang), Shahrul Mt-Isa and Susan Talbot, on behalf of the EFSPI BRA/HTA joint working group

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

by George Quartey

The webinar occurs twice - please register for one of the following dates:
  • 1st webinar: 2017 February 9, 5pm CET (4pm GMT)
  • 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)
Click here to view the flyer!

 Here is some further background information about the content and the presenters:

The emerging and merging fields of benefit-risk and health technology assessments

jason
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies. About the presenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.  

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

georg
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation. About the presenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.

To access the recording, please visit the Video-on-Demand Library.

Webinars

Structured Benefit–Risk Assessment Webinar

Please join our webinar. We'll have 2 presentations from widely known speakers:

The emerging and merging fields of benefit-risk and health technology assessments

by Jason (Jixian Wang), Shahrul Mt-Isa and Susan Talbot, on behalf of the EFSPI BRA/HTA joint working group

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

by George Quartey

The webinar occurs twice - please register for one of the following dates:
  • 1st webinar: 2017 February 9, 5pm CET (4pm GMT)
  • 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)
Click here to view the flyer!

 Here is some further background information about the content and the presenters:

The emerging and merging fields of benefit-risk and health technology assessments

jason
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies. About the presenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.  

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

georg
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation. About the presenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.

To access the recording, please visit the Video-on-Demand Library.

Careers Meetings

Structured Benefit–Risk Assessment Webinar

Please join our webinar. We'll have 2 presentations from widely known speakers:

The emerging and merging fields of benefit-risk and health technology assessments

by Jason (Jixian Wang), Shahrul Mt-Isa and Susan Talbot, on behalf of the EFSPI BRA/HTA joint working group

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

by George Quartey

The webinar occurs twice - please register for one of the following dates:
  • 1st webinar: 2017 February 9, 5pm CET (4pm GMT)
  • 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)
Click here to view the flyer!

 Here is some further background information about the content and the presenters:

The emerging and merging fields of benefit-risk and health technology assessments

jason
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies. About the presenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.  

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

georg
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation. About the presenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.

To access the recording, please visit the Video-on-Demand Library.

Upcoming Events

PSI Introduction to Industry Training (ITIT) Course - 2026/2027

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

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.

AIMS SIG - Open-Source Lunch Bites

Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.

Connecting the False Discovery Rate to Shrunk Estimates

A 1 hour online event, that includes a presentation followed by Q&A. This talk will explore the “replication crisis” in science, focusing on how testing large numbers of hypotheses can lead to false positive findings. It introduces key statistical approaches—False Discovery Rate (FDR) and shrinkage methods—to address this issue, and explains their conceptual foundations and connections. The session will also highlight how these tools can be understood within an empirical-Bayesian framework, linking significance testing with effect size estimation.

PSI Career Young Virtual Event (Q2 2026)

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 Book Club: The AI Con – Joint with ASA Book Club

The Guardian described the authors of this book as refreshingly sarcastic! What is sold to us as AI, they announce, is just "a bill of goods": "A few major well-placed players are poised to accumulate significant wealth by extracting value from other people's creative work, personal data, or labour, and replacing quality services with artificial facsimiles."

PSI Book Club: Another Door Opens – Book Club Special Event

This is a Book Club Special Event in response to the changes in our industry and as a supportive move to create community and connection for those navigating redundancy and uncertainty. Read the book in advance of the book club session then join the zoom call to discuss ideas. There will be breakout groups to connect with others, exchange experiences of how the book has helped, and offer support.

PSI Book Club: Change: How organisations achieve hard-to-image 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.

PSI Career Young Virtual Event (Q3 2026)

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 2026)

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

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