Rethinking Programming Validation and Traceability in Clinical Trials

Rethinking Programming Validation and Traceability in Clinical Trials

Author: Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry May 26, 2026 Duration: 23:24
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.

Hosted by Alexander Schacht and Benjamin Piske, both practicing biometricians and leaders within the pharmaceutical industry, The Effective Statistician-in association with PSI is a conversation about the practical realities of the profession. This isn't a theoretical lecture series; it's a resource built from the ground up by statisticians who navigate the same challenges you do every day. The discussions focus on actionable strategies for increasing your influence and efficiency, whether you're analyzing data, presenting findings, or guiding a team. You'll hear perspectives on developing leadership qualities even without a formal management title, and gain insight into current debates within the scientific and regulatory communities. The aim is to provide context for the health sector's evolving landscape, translating complex industry dynamics into relevant knowledge for your work. Tune in for a candid exploration of what it means to be a modern statistician, designed to help you refine your approach and achieve a more significant impact. This podcast serves as a professional toolkit, created in association with PSI (Promoting Statistical Insight), for statisticians at any career stage looking to deepen their expertise and navigate their roles with greater confidence and clarity.
Author: Language: English Episodes: 100

The Effective Statistician - in association with PSI
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