The Future of Statistical Methodology in Drug Development

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 Ben 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.

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.

In this episode of The Effective Statistician, I speak with Andrew (Andy) York about the evolving world of programming validation, traceability, and quality assurance in clinical trials. Andy has decades of experience in statistical programming, leadership roles across pharma and CROs, and now works with AI-driven solutions focused on improving validation and traceability.

In this episode, Alun Bedding speaks with Richard Zink about how **applied improvisation** can help statisticians become more effective communicators and leaders. They explore how improv techniques—like “yes, and,” active listening, and embracing mistakes—build confidence, strengthen collaboration, and improve the way we explain complex ideas. This conversation shows that developing interpersonal skills doesn’t have to be theoretical or boring—it can be practical, interactive, and even fun. If you want to communicate your ideas more clearly, connect better with stakeholders, and grow beyond technical expertise, this episode is for you.

Episode Overview In this episode, I speak with Anna Mosikian, a physician by training and Global Clinical Program Lead working at the intersection of clinical development and strategic marketing. Anna brings a powerful perspective on how clinical data translates into real-world value—bridging evidence generation, regulatory expectations, and commercial impact. We dive into what clinical leaders truly expect from statisticians and how statisticians can move from technical contributors to strategic partners. We explore what “good collaboration” really looks like in practice, why understanding the purpose of a study is critical, and how statisticians can elevate their impact through communication, proactiveness, and cross-functional thinking.

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.

In this episode, I sit down with Rachael Lawrance to dive into a topic that has become absolutely central to clinical research: patient-centered outcomes. When I first started as a statistician, I knew these measures existed—but I didn’t really understand how they were developed, analyzed, or used in decision-making. That has changed dramatically over the years. Today, patient-reported outcomes (PROs) and the broader framework of clinical outcome assessments (COAs) play a key role in regulatory approvals, payer decisions, and how we demonstrate treatment value. Rachael brings deep expertise from her work at Adelphi Values and shares how these endpoints are developed, validated, and applied in practice. We also discuss how statisticians can contribute more effectively by understanding the science behind these measures—not just treating them as “just another scale.”

pisode Summary 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.

Generative AI is moving fast—and in pharma, it’s no longer just a buzzword. In this episode of The Effective Statistician Podcast, I speak with Manuel Cossio about how Generative AI is already being applied in real-world pharma settings, where it’s delivering value today, and what still needs careful consideration in regulated environments. Manuel brings a unique hybrid background, combining molecular biology, genetics, pharma experience, and deep AI engineering expertise. He works at the cutting edge of AI in clinical development, including agentic systems, human-in-the-loop approaches, and large-scale document automation. This conversation goes well beyond theory. We focus on practical use cases, real limitations, and how statisticians, programmers, and data scientists can responsibly use GenAI to become more effective.

As we start 2026, I want to take a moment to express my sincere gratitude to everyone who has been part of The Effective Statistician podcast. This episode features my co-host, Alun Bedding, reflecting on the past year and sharing thanks on behalf of both of us. From our listeners who tune in, share episodes, and engage with the content, to our guests who generously share their expertise and real-world experiences — your participation makes this podcast both insightful and practical for statisticians worldwide. I also want to recognize Reine and her production team. So much of the work that brings each episode to life happens behind the scenes, and we are deeply grateful for their professionalism and dedication. We’re excited about what 2026 has in store. I look forward to continuing this journey with all of you and bringing even more valuable conversations to our community.