Dr. Alexander Schacht

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In this episode, I talk with Ning Leng, Ph.D., Director II, Data and AI Acceleration Group, Data & Statistical Sciences at AbbVie, about the growing role of the R Consortium in the pharmaceutical industry.

Ning brings extensive experience in statistics, computational genomics, open-source technology, and the adoption of R across the pharmaceutical industry. Before joining AbbVie, she spent 10 years at Roche Genentech, where she helped drive the adoption of R, cloud technologies, Git, and Shiny.

We discuss how the R Consortium creates a platform for statisticians, programmers, pharmaceutical companies, and regulators to collaborate on practical challenges—and how that collaboration is changing the way we approach regulatory submissions.

Why you should listen

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How the R Consortium Is Transforming Regulatory Submissions and AI in Clinical Trials

Dr. Alexander Schacht

All Episodes

In this episode, I talk with Ning Leng, Ph.D., Director II, Data and AI Acceleration Group, Data & Statistical Sciences at AbbVie, about the growing role of the R Consortium in the pharmaceutical industry.

Ning brings extensive experience in statistics, computational genomics, open-source technology, and the adoption of R across the pharmaceutical industry. Before joining AbbVie, she spent 10 years at Roche Genentech, where she helped drive the adoption of R, cloud technologies, Git, and Shiny.

We discuss how the R Consortium creates a platform for statisticians, programmers, pharmaceutical companies, and regulators to collaborate on practical challenges—and how that collaboration is changing the way we approach regulatory submissions.

Why you should listen

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Dr. Alexander Schacht

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Cancer treatments have changed dramatically over the past decade, but have our dose-finding strategies kept pace?

In this episode, I speak with Dr. Ayon Mukherjee, who leads statistical innovation in early oncology development at Eli Lilly. Together, we explore Project Optimus, the FDA initiative that is changing how we think about dose optimization in oncology.

Instead of simply finding the highest dose patients can tolerate, Project Optimus encourages us to identify the dose that provides the best balance between efficacy, safety, pharmacokinetics, pharmacodynamics, and long-term tolerability.

Ayon explains why the traditional maximum tolerated dose approach worked well for chemotherapy but often falls short for targeted therapies and immunotherapies. We also discuss how statisticians can help lead this transformation by designing better dose optimization studies and collaborating more effectively with clinicians, pharmacologists, and regulators.

Why you should listen

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Project Optimus and what you need to know about it

Dr. Alexander Schacht

All Episodes

Cancer treatments have changed dramatically over the past decade, but have our dose-finding strategies kept pace?

In this episode, I speak with Dr. Ayon Mukherjee, who leads statistical innovation in early oncology development at Eli Lilly. Together, we explore Project Optimus, the FDA initiative that is changing how we think about dose optimization in oncology.

Instead of simply finding the highest dose patients can tolerate, Project Optimus encourages us to identify the dose that provides the best balance between efficacy, safety, pharmacokinetics, pharmacodynamics, and long-term tolerability.

Ayon explains why the traditional maximum tolerated dose approach worked well for chemotherapy but often falls short for targeted therapies and immunotherapies. We also discuss how statisticians can help lead this transformation by designing better dose optimization studies and collaborating more effectively with clinicians, pharmacologists, and regulators.

Why you should listen

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Dr. Alexander Schacht

All Episodes

In this insightful interview, Emma May and Alun Bedding explore the nuances of coaching and mentoring, sharing personal stories, frameworks, and practical tips to enhance professional growth. Discover how these powerful tools can transform statisticians’ careers and foster leadership development.

Key Topics:

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Unlocking Growth: The Power of Coaching and Mentoring for Statisticians

Dr. Alexander Schacht

All Episodes

In this insightful interview, Emma May and Alun Bedding explore the nuances of coaching and mentoring, sharing personal stories, frameworks, and practical tips to enhance professional growth. Discover how these powerful tools can transform statisticians’ careers and foster leadership development.

Key Topics:

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Dr. Alexander Schacht

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External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations.

In this episode, I speak with Benjamin Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges.

If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.

Key Topics:

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Understanding and Mitigating Endpoint Bias in External Control Arms

Dr. Alexander Schacht

All Episodes

External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations.

In this episode, I speak with Benjamin Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges.

If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.

Key Topics:

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Dr. Alexander Schacht

All Episodes

This episode features three leading statistical methodology experts discussing the role, impact, and future of methodology groups in the pharmaceutical industry. They explore organizational structures, skill sets, AI integration, and strategies to accelerate adoption of innovative methods.

Key Topics:

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The Future of Statistical Methodology in Drug Development

Dr. Alexander Schacht

All Episodes

This episode features three leading statistical methodology experts discussing the role, impact, and future of methodology groups in the pharmaceutical industry. They explore organizational structures, skill sets, AI integration, and strategies to accelerate adoption of innovative methods.

Key Topics:

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Dr. Alexander Schacht

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Trust is one of the most fundamental elements of effective leadership—and yet, most organizations don’t measure it properly.

In this episode, I speak again with my good friend Alun Bedding about how we can move from talking about trust to actually quantifying and improving it. We explore why trust is essential for collaboration, leadership, and performance, and what happens when it’s missing.

We also dive into practical tools like the Leadership Trust Index, how to interpret trust as a lead measure, and how organizations can systematically improve trust over time.

If you want to become a more effective leader and create real impact, this episode gives you both the mindset and the tools to do it.

Why You Should Listen:

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Measuring Trust – A Key to Effective Leadership

Dr. Alexander Schacht

All Episodes

Trust is one of the most fundamental elements of effective leadership—and yet, most organizations don’t measure it properly.

In this episode, I speak again with my good friend Alun Bedding about how we can move from talking about trust to actually quantifying and improving it. We explore why trust is essential for collaboration, leadership, and performance, and what happens when it’s missing.

We also dive into practical tools like the Leadership Trust Index, how to interpret trust as a lead measure, and how organizations can systematically improve trust over time.

If you want to become a more effective leader and create real impact, this episode gives you both the mindset and the tools to do it.

Why You Should Listen:

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Dr. Alexander Schacht

All Episodes

In this episode of The Effective Statistician, Alun Bedding speaks with Emma May about the skills that truly differentiate effective statisticians from great leaders.

While technical expertise remains essential, success in today’s environment increasingly depends on the ability to build trust, communicate effectively, and lead with emotional intelligence. Drawing from their joint leadership workshops, Alun and Emma explore how statisticians can develop these capabilities and apply them in real-world settings.

They discuss practical approaches to creating psychological safety, shifting from a “telling” to a coaching mindset, and fostering a growth mindset within teams. The conversation highlights why leadership is not about having all the answers—but about enabling others to contribute, grow, and succeed.

Why You Should Listen

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How Statisticians Can Build Trust and Lead with Emotional Intelligence

Dr. Alexander Schacht

All Episodes

In this episode of The Effective Statistician, Alun Bedding speaks with Emma May about the skills that truly differentiate effective statisticians from great leaders.

While technical expertise remains essential, success in today’s environment increasingly depends on the ability to build trust, communicate effectively, and lead with emotional intelligence. Drawing from their joint leadership workshops, Alun and Emma explore how statisticians can develop these capabilities and apply them in real-world settings.

They discuss practical approaches to creating psychological safety, shifting from a “telling” to a coaching mindset, and fostering a growth mindset within teams. The conversation highlights why leadership is not about having all the answers—but about enabling others to contribute, grow, and succeed.

Why You Should Listen

Weiterlesen …