Role of Statistician in the era of personalized medicine – perspectives from Academia, Regulatory and Pharmaceuticals Industry
*Janet Wittes, Statistics Collaborative 

Keywords: Personalized medicine; Statistical art; Translational statistics

In the era of personalized medicine with rapid evolving science and technologies across multiple disciplines, the need to stress “Roles of Statisticians” has apparently become a pertinent and pressing issue that has not been adequately addressed in the realm of “Roles of Statistics.” Incorporating and anticipating scientific and technological advances and the ability to bridge statistics to other fields are necessary for successful collaborations of statisticians with medical professionals and scientists.

There is no doubt that further development in analyses and methodologies is both fundamental and critical for practicing statisticians. This single aspect alone is far from sufficient to ensure successful collaboration and leadership in multidisciplinary environment including not only project teams, regulatory agencies, but also medical and patient communities.

Developing the ability to broaden advancing scientific knowledge and to incorporate new technologies is of parallel importance to developing communication and interpersonal skills. Being able to properly blend and apply these skills in a particular context of research while taking into considerations of various practical, regulatory and ethical issues is a “statistical art” that is at the core of “Roles of Statisticians”.

This “statistical art” can take various forms, which encompass demands of statisticians "asking the right questions”, "making investigators confront their own assumptions”, “using both statistical reasoning and common sense”, “having ability to bridge between statistics and other disciplines”, “showing leadership in driving the integration of science and technology advances with innovative clinical development”, etc. Playing the roles well also motivate the development of innovative and relevant statistical theory and methodology.

In this Town Hall meeting, we aim to broaden our own view of the roles of statisticians as well as to learn the viewpoints held by medical research and public health personnel in this new ear of personalized medicine. We will investigate barriers which prevent statisticians from performing more effectively, explore the journey of successful statisticians, and present some examples of critical roles of statisticians. The session will include a panel of well-known statistical and medical experts who will speak from their own experiences to address these issues.

Keynote speech: 1. Future evolution of the statistician’s role in drug development: What qualifies as “good statistical practice”? (Robert Califf) 2. Role of Statisticians on both sides of the drug development (Lisa LaVange) 3. Core competencies for statisticians in pharmaceuticals industry (Jeffrey Helterbrand)

Panel discussion on various questions from Panelist members: Robert Califf, FDA –Deputy commissioner; Lisa LaVange,FDA-CDER Biostatistics; Jeffrey Helterbrand, Industry (Roche), Janet Wittes,Consulting(Statcollab); Tom Fleming, Academic (Univ. of W); Robert Temple,FDA –Medical; Sonia Davis, Academic (UNC); Ramachandran Suresh,Industry (GSK)