Industry AI Spotlight

Industry AI Spotlight

The Impact of AI and Automation on Statistical Programming: Opportunities, Risks, and the Path Forward

Tuesday, June 2, 1:30 – 3:00 PM
Ensemble Ballroom B

Panelists

Amy Gillespie

Amy Gillespie

Associate Vice PresidentMerck & Co.Read Bio
Francis Kendall

Francis Kendall

Executive Director, Head of Statistical Programming, Digital and Data SciencesBiogenRead Bio
Qin Li

Qin Li

Head of Statistical ProgrammingRegeneron Pharmaceuticals, Inc.Read Bio
Mariann Micsinai-Balan

Mariann Micsinai-Balan

VP, Global Head of Analytical Data ScienceGenentech/RocheRead Bio
Dan Schramek

Dan Schramek

Head, RII & OncologyGSKRead Bio

Automation and artificial intelligence (AI) are rapidly reshaping statistical programming within regulated clinical development environments. Advances in automated workflows, AI-assisted coding, and intelligent validation promise efficiency gains, yet they also introduce new challenges related to quality, reproducibility, governance, and regulatory compliance. As organizations operate under GCP and inspection-readiness expectations, statistical programming leaders must carefully balance innovation with rigor, ensuring that emerging technologies enhance trust in clinical trial deliverables. Equally important is understanding how these technologies affect the people who design, execute, and oversee statistical analyses.

Step into the Industry Leadership Spotlight on AI and Automation to hear directly from senior leaders who are turning these challenges into opportunities. Heads of statistical programming from major pharmaceutical companies will share how they are:

  • Modernizing workflows with automation and AI-assisted coding while preserving quality, reproducibility, and regulatory compliance
  • Embedding governance and inspection readiness into new ways of working
  • Elevating and reskilling statistical programmers so that people grow alongside the technology

Join this session to gain practical, leadership-level insight into how to adopt AI and automation responsibly and confidently within regulated clinical environments.