The Future of Biostatistics: Insights from Presenters at PSI 2026

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Navigating Complexity Through Simulation

For Andrew Mills, Strategic Principal Statistician, the importance of simulation in clinical trial design was a central theme of his presentation. He emphasized that while experience and expertise remain invaluable, they are not always enough when dealing with complex study design decisions.

“Effective study design balances on the ability to understand and mitigate uncertainty. Intuition and expertise will get us in a close proximity, but often with an undefined ‘grey area’ which we can define using quantitative outputs from a simulation exercise.”

Looking ahead, Andrew believes simulation will play an increasingly important role in shaping discussions between sponsors and regulators, particularly in oncology.

“I see it acting as the basis of future guidance for sponsors and potentially regulators to create more streamlined discussions around how to define and identify harm in oncology clinical trials.”

Reflecting on the conference, Andrew noted strong engagement around regulatory guidance, simulation best practices, and shared industry challenges.

“It was very interesting to hear how others are experiencing similar problems, displaying the appetite amongst conference attendees to gain insight into these topics.”

Embracing a Growth Mindset in a Changing Industry

Amy Spencer, Senior Biostatistician, presented on the Growth Mindset Framework and its relevance for statisticians navigating an evolving professional landscape. Her goal was to introduce attendees to a practical approach for continuous learning and career development.

“I hope I gave a good introduction into the idea of the Growth Mindset Framework and an insight on the wide range of activities an FSP statistician can be involved in.”

Amy encouraged attendees to consider how adopting a growth mindset could support their own development, regardless of their role.

“It would be fantastic if the audience went away considering how they could apply the Growth Mindset Framework to helping them grow, learn and develop in their careers. “With AI, new technologies, and ongoing industry transformation becoming increasingly prominent topics, Amy sees the framework becoming even more relevant in the years ahead.

“Using the Growth Mindset Framework is an ideal tool to help us move forward through change and to deal with the adoption of new technologies, so I hope that it becomes something that is widely adopted.”

Among her highlights from PSI were sessions on adaptive and Bayesian trial designs, as well as a memorable plenary session on effective communication.

Managing Change Through Effective Communication

Frances Denny, Director, Business Operations, used her panel to explore change management within the pharmaceutical industry, using real-world examples to illustrate how organizations and individuals respond to transformation.

“Change in the industry is continuous. It’s important to communicate regularly and effectively to your intended audience when implementing any significant changes.”

The session used storytelling to examine four distinct examples of industry change, ranging from AI and technology adoption to mergers and acquisitions, strategic organizational change, and the lasting impact of COVID-19.

“We provided four clear examples of change in the industry, each focusing on a different aspect of a typical change curve that someone might go through when change management is in place.”

Frances believes these examples reflect broader industry trends, particularly as organizations adapt to emerging technologies and evolving regulatory requirements.

“There are lots of changes going on, with the industry getting to grips with AI and its impact both on the industry as a whole and on the role of a statistician.”

She also highlighted the importance of continued learning and development, especially in areas such as simulation and adaptive design, which were recurring themes throughout the conference.

Harnessing AI to Improve Clinical Research Communication

For Lesedi Ledwaba-Chapman, Software Engineer, one of the key messages from this year’s conference was the pace at which both AI and Bayesian methodologies are moving from theory into practice. While AI continues to generate significant attention across the industry, Lesedi noted that recent FDA guidance has also sparked renewed interest in Bayesian approaches to clinical trial design.

“While AI represents the cutting edge, Bayesian methods are seeing a massive resurgence driven by recent FDA guidance. The real takeaway is how both are rapidly moving into mainstream implementation, actively reshaping clinical trial design and our daily operational efficiency.”

As part of the AI & ML Special Interest Group (SIG) session, Lesedi’s presentation explored how large language models (LLMs) can help streamline clinical document generation. Looking ahead, he sees AI playing a much broader role in making clinical research more accessible to patients.

“Our AI & ML SIG session showed that LLMs can streamline clinical document generation. Moving forward, AI will democratize complex trial data for patients. We will use it to translate dense documents into plain language, helping patients fully understand the trial before enrolling and clearly grasp the outcomes after participating.”

Reflecting on PSI 2026, Lesedi highlighted both the scientific content and the opportunity to connect with peers across the industry.

“The sheer quality of the presentations was incredible and inspiring; I thought about the methodologies for days afterward. Beyond the science, networking face-to-face with peers was a massive highlight.”

He also pointed to the conference’s social program as a memorable part of the experience, “the gala dinner at Titanic Belfast provided a spectacular backdrop to celebrate our community.”

A Conference Focused on Learning, Collaboration, and the Future

Across all four presentations, several themes emerged consistently: the growing importance of simulation, the need to embrace change, the impact of AI on the future of biostatistics, and the value of continuous professional development. Alongside the technical content, PSI once again demonstrated the importance of bringing together professionals from across the industry to share experiences, challenges, and new ideas.

As Amy reflected, one of the greatest strengths of the conference remains the opportunity to connect with colleagues and learn from one another. Combined with the insights shared across the program, PSI 2026 reinforced that while the industry continues to evolve, collaboration, learning, and innovation will remain at the heart of its progress.