The Verisian Podcast

Description In this episode of the Verisian Community Podcast, host Tomás Sabat Stöfsel is joined by Henning Kuich, CTO of Verisian, and Andrew York, strategic advisor to Verisian and former Vice President of Data Science at Novo Nordisk. Andy has nearly 40 years of experience within biostatistics and biometrics, across the pharmaceutical industry. Henning, Andy and Tomás discuss the pharmaceutical industry’s shift from SAS to R, and what happened when Verisian’s AI agents rebuilt the R Consortium’s FDA-reviewed Pilot 3 submission from scratch. No human wrote a single line of code, frontier AI models ignored their guardrails and copied the public code, half of the custom specifications couldn’t be implemented as written, and the reference package contained a discrepancy double programming would never have caught. Henning and Andy also explain why validation, not code generation, is the real bottleneck, and how the role of the statistical programmer is changing as AI takes on more of the coding.   In this conversation, we explore: Why the industry is moving from SAS to R, and how far that shift has come in 2026 How Verisian’s AI agents rebuilt the R Pilot 3 ADaM datasets without a human writing any code Why frontier AI models ignored guardrails, and how traceability caught it Why ambiguous specifications prevent both AI automation and validation How the role of the statistical programmer is changing as AI generates more code   00:00 - Introduction to the Verisian Community Podcast 01:40 - Why the industry is moving from SAS to R 05:00 - Rebuilding the R Consortium Pilot 3 submission with AI agents 14:55 - When AI models cheat 19:20 - How widely is AI used in statistical programming, and what are the risks? 23:45 - Pilot 3 results: specification quality and the Verisian Planner 36:45 - How validation works in the Verisian platform 45:45 - Why naive AI approaches don’t work in clinical trials 52:00 - Human in the loop: the changing role of the statistical programmer 57:45 - Advice for programmers worried about AI 1:02:15 - The cumulative dose discrepancy in Pilot 3 1:05:20 - Final thoughts   About the Verisian Podcast The Verisian Podcast brings together clinical trial experts to share ideas and best practices in clinical reporting, submission and review. Guests include statistical programmers, biostatisticians and medical writers, discussing the technologies shaping the future of clinical development. Listen on YouTube, Apple Podcasts and Spotify.   Resources: Verisian platform: https://www.verisian.com/ Verisian on LinkedIn: https://www.linkedin.com/company/verisian/ Listen on: YouTube: https://www.youtube.com/@verisianHQ  Spotify: https://open.spotify.com/show/6EnSKNpv5ENwDTIElqRDxW  Apple Podcasts: https://podcasts.apple.com/us/podcast/the-verisian-community-podcast/id1719471109

Description Andrew York has over 30 years experience as a statistical programmer and biostatistician. From the beginning of his career as a statistician at Roche, to his current role as Clinical Data Science Vice President at Novo Nordisk, Andy has seen the industry evolve and has played a leading role in shaping best practice in the industry. Reflecting on these experiences, in this episode Andy shares his unique perspectives on the evolution of statistical programmers. Alongside this, Tomás and Andy discuss open-source programming, where the industry would be without standards, and the need for standards that are more sympathetic to AI and automation driven processes. Andy also explains why achieving full end-to-end traceability currently poses such a challenge, and why doing so has immense benefits to changing how we program studies today. In this conversation, we explore: The history of statistical programming and how the modern statistical programmer came to be Standards and their role in driving the industry forward Opportunities and challenges of open source programming Traceability and its potential in changing how we build and validate programs today The future of statistical programming and how AI will transform current ways of working   00:00 - Introduction to the Verisian Community Podcast 02:03 - The history of statistical programming and Andrew’s journey within the industry 12:19 - Where would the industry be without standards? 21:14 - Adoption of open source 36:07 - Building a computing environment 40:11 - How can traceability transform statistical programming? 52:06 - How AI will impact the future of statistical programming 01:09:25 - The changing role of a statistical programmer 1:12:14 - Rapid fire questions   About The Verisian Community Podcast The Verisian Community Podcast brings together experts in clinical trials to exchange innovative ideas and best practices central to clinical reporting, submission and review. Aligned with Verisian's mission to accelerate the evaluation and market launch of new medical treatments, each episode features expert insights, with guests ranging from statistical programmers to medical writers, to discuss the challenges and opportunities of the latest software and technology.   Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community  Follow us on LinkedIn: https://www.linkedin.com/company/verisian/      Listen on: Spotify: https://open.spotify.com/show/6EnSKNpv5ENwDTIElqRDxW  Apple Podcasts: https://podcasts.apple.com/us/podcast/the-verisian-community-podcast/id1719471109 

Description Josef von Rickenbach is a true pioneer in the pharmaceutical industry. In 1982, he co-founded Parexel, a company that would go on to define the CRO industry as we know it today. Over the next 36 years as CEO, he led over 40 acquisitions, scaled the company to 19,000 employees, and helped set industry standards that still shape biopharma today. But Josef’s story isn’t just about business. It’s a story of relentless execution, risk-taking, and building an entirely new industry from scratch. Convincing pharma companies to outsource clinical research - an idea that was unheard of at the time - took vision, persistence, and an ability to see patterns before others did. In this conversation, we explore: How he identified the unmet need that led to the birth of the CRO industry The hardest moments of scaling Parexel from a 2-person consultancy to a global powerhouse How he sees the future of clinical development, including the role of AI in drug development Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/

Episode Summary Double programming has long been the industry standard for validation in statistical programming, but is it the most effective approach? In this episode, Henning Kuich, Richardus Vonk, Sunil Gupta and Tomás Sabat Stöfsel discuss how code traceability is transforming the validation process, enhancing transparency, improving efficiency, reducing costs and enabling better collaboration across teams. The conversation explores the limitations of traditional validation methods, the potential of modern technology to streamline workflows, and the implications for the future of statistical programming. Watch now to learn about the evolution of validation and the opportunities ahead. Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/

Episode Summary In this episode, we sit down with David, an expert in R programming for clinical trials, to discuss the evolving landscape of statistical programming. From his unconventional journey from journalism and philosophy into programming to his deep insights on the maintainability and stability of R in the pharmaceutical industry, David shares his perspective on the challenges and opportunities of open-source programming. He explores the key differences between R and SAS, the critical importance of backward compatibility, and how organizations can future-proof their R-based systems. David also introduces his work on PackageDiff, a tool aimed at addressing package stability, and shares his thoughts on AI's role in the space. This is a must-listen for anyone working with R in regulated environments. Biography David David J. Bosak is the Chief Software Architect at Archytas Clinical Solutions. He has been a consultant to pharma and non-pharma companies for over 25 years. He has extensive experience creating solutions in SAS, .NET, database, and web technologies. Currently obsessed with R, he has become an active package developer, and has ten R packages published on CRAN. Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/

Episode Summary In this episode of the Verisian Community Podcast, Katja explores the huge potential of open-source tools in clinical development. She discusses how platforms like OpenStudyBuilder are revolutionizing study design and collaboration within the pharma industry. Katja shares her experiences in overcoming resistance to open-source adoption, addressing challenges like regulatory constraints and industry skepticism. The conversation delves into the evolving role of traditional tools like SAS alongside modern languages such as R and Python. Katja closes with a forward-looking vision for how open-source technology can reshape the future of clinical development and regulatory submissions over the next decade. Biography Katja As open source consultant, Katja hosts a portal about open-source solutions for Pharma (www.glacon.eu/portal) and provides open-source consulting. Her key experiences are SAS, Web Technologies, ADAM, Define.xml and the TLF generation where she worked for several years at Bayer. Additionally, she is the community manager for the OpenStudyBuilder open source project, is a board member of the CDISC Open Source Alliance and part of the PHUSE Open Source Technology in Clinical Data Analysis Board. Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/

Episode Summary In this episode, Shafi discusses his decades-long journey and what led him into the world of statistical programming. He shares insights into the evolution of automation in clinical trials, its role in transforming traditional tasks like validation and double programming, and the impact AI is having on oversight and traceability for large teams. Shafi also addresses the ongoing challenges in scaling AI for clinical trial reporting and how embracing these technologies is critical for staying ahead in the evolving landscape of the industry. Biography Shafi Shafi has been a programmer in the pharmaceutical industry for 30 years and holds an MSc. in Statistics. After working for CROs and Pharma companies across Europe, he founded Shafi Consultancy in 2001 to support statistical programming from their offices in the UK and Bangladesh. Shafi is driven by helping others to become skilled programmers and by innovating to improve process efficiency in the industry. To this end, his team has developed training videos and applications for Risk-Based Monitoring, Visualisation and automation of clinical programming activities in Metalytics, that auto-generates programs and removes the mundane, routine and repetitive tasks. Shafi believes that an open discussion of ideas helps the industry to continuously develop and has been a regular presenter at industry conferences like Phuse, PSI and PAGE for almost 20 years. Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/

Episode Summary In this episode, Nijat from Lindus Health shares their vision for building the future of clinical trials by creating what they call the "anti-CRO." He dives into Lindus Health's mission and his personal passion for driving change in this space. Nijat explores the challenges of innovation in clinical trials, particularly the complexity of aligning trials with patient needs while navigating the demands of various stakeholders. Nijat sheds light on how Lindus Health is addressing these challenges and redefining the clinical trial process to better serve patients and the industry alike. Biography Nijat Hasanli Nijat is the Head of Product at Lindus Health, an end-to-end clinical trial delivery company. He was founding members at OneCommerce and Downforce where he led product development. He has a PhD in Inorganic Chemistry from Oxford University where he focused on design of novel semiconductor and battery materials. Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/

Episode Summary In this episode of the Verisian Community Podcast, we welcome Sunil Kumar Pusarla to share his journey and insights from over 20 years in statistical programming. Sunil discusses the skills and traits essential for success as a statistical programmer, addressing the challenges and pressures that professionals face today. He emphasizes the importance of maintaining high-quality standards, even under tight deadlines, and compares the distinct cultures and expectations of big pharma versus smaller biotech companies. Sunil also explores how technological advancements are reshaping the role of statistical programmers and offers his vision for how the field will evolve over the next decade, including the new skills that will become crucial in the future. Biography Sunil Kumar Pusarla He acquired base and advanced SAS certifications as well as a couple of R certificates from HarvardX. He presented a few papers on SAS user conferences on techniques to help clinical and statistical programmers. His career at Omeros started as a SAS programmer and now he is leading the department as Sr. Director of Statistical Programming. He was involved in 4 successful regulatory filings and 3 of them got drug approvals. Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/

Episode Summary In this episode of the Verisian Community Podcast, Richardus Vonk discusses the transformative role of AI in clinical trials. He explores how AI is reshaping trial planning and execution, improving early disease detection like cancer, and the challenges it still faces in drug development. Richardus also highlights the benefits of automation in freeing up time for deeper scientific exploration and elaborates on the tactical versus strategic use of AI and GenAI. The conversation touches on the rise of open-source tools, balancing data sharing with patient privacy, while offering a vision for the future of clinical trials over the next decade. Biography Richardus Vonk Richardus Vonk, Biostatistics Leader, Entrepreneur, Advisor Richardus is a distinguished leader in quantitative decision-making within pharmaceutical clinical development, with over 30 years of extensive experience. He is a passionate advocate of leveraging data to enhance the success of drug development programs, emphasizing how actionable insights provide a competitive edge. Previously serving as the VP and Head of Oncology Data Analytics and Statistical Sciences at Bayer AG, Richardus now advises a diverse range of organizations in the life sciences and pharmaceutical sectors, including software companies and start-ups. He focuses on unlocking the potential of clinical and real-world data as well as advanced data-science technologies to innovate and transform the clinical trial landscape. Resources Learn more about us: https://www.verisian.com/ Join the Verisian Community: https://www.verisian.com/community Follow us on LinkedIn: https://www.linkedin.com/company/verisian/