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.

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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 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.

**Why You Should Listen

**Episode Highlights

**About Ben Ackerman

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.

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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.

We discuss why traditional approaches to validation are becoming increasingly difficult to sustain, how expectations from regulators continue to grow, and why traceability is far more than just linking programs and datasets.

Andy also shares how modern AI-powered tools can automatically map programming workflows, connect datasets and outputs, and create end-to-end traceability from raw data to final tables, figures, and listings.

If you work with statistical programming, clinical data workflows, submissions, or validation processes, this episode will challenge some long-held assumptions and introduce you to where the future may be heading.

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In this episode, I hand over the mic to Alun Bedding, who speaks with Richard Zink about a topic that might surprise many statisticians: applied improvisation.

At first glance, improv may seem unrelated to statistics or leadership. But as Richard shares his journey—from a biostatistician and software developer to an improv practitioner—it becomes clear how powerful these skills are for communication, collaboration, and leadership.

We explore how improv techniques help you think on your feet, listen deeply, support others, and communicate more effectively—all critical skills for statisticians working in complex, cross-functional environments.

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…then this episode is for you.

Applied improvisation offers a practical, hands-on way to strengthen interpersonal skills—without boring theory. Instead of reading about communication, you experience it.

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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.

If you want to become a more effective statistician—not just technically strong but highly valued in your organization—this episode is for you.

01:31 – Why trust is the foundation of everything

02:01 – If you can’t measure it, you can’t improve it

03:29 – Trust across all relationships

04:29 – The cost of low trust

05:27 – Organizations say trust matters—but don’t measure it

06:25 – The clinical trial analogy

07:25 – Start by removing trust-destroying behaviors

08:19 – Trust as a lead measure

10:16 – Evidence: why trust drives performance

11:14 – The Leadership Trust Index

13:38 – How to implement trust surveys

16:04 – Action builds trust—not surveys alone

18:21 – Trust is built through consistent delivery

20:41 – The 3 Cs of trust

22:32 – Simple ways to build trust today

24:00 – Bringing trust measurement into your organization

26:25 – Final takeaway

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Rachael Lawrance

Rachael is a highly experienced statistician specializing in patient-centered outcomes. She works across the full lifecycle of PRO development—from qualitative research and questionnaire design to statistical validation and interpretation.

With a background in pharma and consultancy, she focuses on bridging the gap between rigorous statistical methodology and meaningful patient insights.

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**Why You Should Listen

**What You Will Learn in This Episode

**Episode Highlights

[00:04:00] Beyond technical expertise

[00:06:00] Emotional intelligence and career success

[00:07:00] Understanding emotions in practice

[00:10:00] The role of instinct vs rational thinking

[00:12:00] Creating psychological safety in teams

[00:18:00] Speaking up and being brave

[00:22:00] From advising to coaching

[00:25:00] Leadership as partnership

[00:28:00] Trust as the foundation of leadership

[00:30:00] Developing a growth mindset

[00:34:00] The value of humility in leadership

[00:36:00] One key leadership habit curiosity

[00:37:00] The power of silence

About the Guest

Emma May

If you’re curious about Generative AI but unsure how it truly fits into clinical development, medical writing, or statistical programming, this episode will give you clarity.

We talk openly about:

✔ What’s actually working right now in pharma

✔ Where GenAI can save significant time and reduce burnout

✔ How to use AI safely in regulated environments

✔ What to watch out for when it comes to hallucinations, governance, and data protection

Whether you’re a statistician, programmer, data scientist, or biometrics leader, this episode will help you see where AI can realistically support your work—and where human expertise remains essential.

🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician.

🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.

🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.

🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities.

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