The Statistical Innovation Community

Welcome to the Statistical Innovation Community

From Applying Innovation to Building an Innovative Culture

The Statistical Innovation Community Summit brings together statisticians from the FDA, academia, and pharmaceutical companies to discuss how statistical innovation efforts can optimally enhance medical product development.

Mission

Our mission is to foster collaboration and knowledge sharing among statistical innovators, promoting best practices that accelerate the development of new medical products for patients while maintaining the highest standards of scientific rigor.

Key Focus Areas

  • Regulatory Innovation: Collaborative approaches with health agencies including the FDA’s Complex Innovative Trial Design (CID) Program
  • Methodological Advancement: Development and implementation of cutting-edge statistical methods
  • Organizational Excellence: Building effective statistical innovation groups and cultures within pharmaceutical organizations
  • Career Development: Defining clear career paths for statistical innovators

Recent Highlights

2024 Summit (September 24, 2024)

Location: Amgen, Rockville, MD

Key themes discussed:

  • Good practices leading to success in statistical innovation
  • Challenges facing innovation groups
  • Future directions for the statistical innovation community

2023 Inaugural Summit (November 9, 2023)

Location: Regeneron Pharmaceuticals, Tarrytown, NY

The inaugural summit brought together over 100 participants from more than 20 pharmaceutical companies, the FDA, and academic institutions.

Community Impact

The statistical innovation community plays a crucial role in:

  • Accelerating drug development timelines
  • Improving trial efficiency and patient outcomes
  • Advancing regulatory science
  • Building bridges between industry, academia, and regulatory agencies

Get Involved

Join our growing community of statistical innovators who are shaping the future of pharmaceutical research and development.

The Statistical Innovation Community Summit is supported by the ASA Biopharmaceutical Section and leading pharmaceutical organizations.