This year, the ASA’s Biopharmaceutical Section will celebrate the International Year of Statistics at the Joint Statistical Meetings in Montréal. The section will sponsor two short courses, five invited sessions, 27 topic-contributed sessions and contributed sessions, and eight roundtable discussions.

One of the section’s two short courses “Design and Analysis of Non-inferiority Trials” will be taught on August 3, by Excellence in CE Award–winning instructor Brian Wiens. Wiens is an author of numerous articles in the area of non-inferiority, a topic that is important to any statistician working in late phase clinical trials. On August 5, an overview of key considerations for statisticians working in clinical trials will be presented in “Analysis of Clinical Trials: Theory and Applications,” taught by Devan Mehrotra, Alexei Dmitrenko, and Jeff Maca.

For a full list of sessions sponsored by the Biopharmaceutical Section, visit the JSM online program.

The following is a list of a few sessions to pique your interest:

Sunday, August 4

• Censoring Issues in Survival Analysis, organized by Grace Liu of Janssen R&D
• Regulatory Considerations on Design and Analysis of Observational Studies, organized by Lilly Yue of FDA

Monday, August 5

• Analysis of Recurrent Events in the Presence of Competing Risks and Informative Censoring, organized by Byron Jones of Novartis
• Issues in Building Imputation Models for Missing Data Techniques, organized by Robert Small of Sanofi-Pasteur
• Impact of Bayesian Methods in Medical Product Development, organized by Karen Price of Eli Lilly

Tuesday, August 6

• Statistical Innovations Developed for Cancer Clinical Trials, organized by Ying Wan of Janssen R&D
• Critical Aspects of Dose-Finding in Drug Development, organized by David Ohlssen of Novartis
• Regulatory Challenges of Nonclinical Biostatistics, organized by Pryia Kulkarni of Genentech

Wednesday, August 7

• Highlights of a Special Issue of SBR in Honor of Robert ONeill’s Tenure as Director of the Office of Biostatistics at FDA, organized by Steven Snappin of Amgen
• The Affordable Healthcare Act’s Statistical Challenges, organized by Alan Sampson of the University of Pittsburgh
• Missing Data in Noninferiority Trials, organized by Brian Wiens of Alcon

Thursday, August 8

• Challenges in Evaluation of Correlates of Protection and Immunobridging of Vaccine Trials, organized by Ivan Chan of Merck
• Challenging Statistical Issues in Medical Device Trials, organized by Yonghong Gao of the FDA

So many of the contributed submissions are excellent, so we urge you attend them. The poster sessions are great if you like having a one-on-one discussion with the authors.

This year, we also have a novel hybrid presentation, the SPEED session (like speed-dating … only better). In the SPEED session, chaired by Lisa LaVange of FDA, you will hear up to 20 five-minute talks. In the following session, you will have the opportunity to talk with the authors and enjoy refreshments. This is our first foray into this approach, and we would like feedback from both presenters and meeting attendees.

Our section also will sponsor eight roundtable discussions and hold a reception and business meeting. For details and registration information, visit the JSM website.