Department of Biostatistics

Zelen Award

Marvin Zelen Leadership Award in Statistical Science

This Year’s Winner

marie davidianWe are extremely pleased to announce that Dr. Marie Davidian will be the recipient of the 2021 Marvin Zelen Leadership Award in Statistical Science!

Please join us for her virtual lecture on:
Thursday, May 6, 2021 | 1-2pm
See Seminar & Events page for secure Zoom link

Estimating Vaccine Efficacy Over Time After a Randomized Study is Unblinded

The COVID-19 pandemic due to the novel coronavirus SARS CoV-2 has inspired remarkable breakthroughs in the development of vaccines against the virus and the launch of several phase 3 vaccine trials in Summer 2020 to evaluate vaccine efficacy (VE).  Trials of vaccine candidates using mRNA delivery systems developed by Pfizer-BioNTech and Moderna have shown substantial VEs of 94-95\%, leading the US Food and Drug Administration to issue Emergency Use Authorizations and subsequent widespread administration of the vaccines.  As the trials continue, a key issue is the possibility that VE may wane over time. Ethical considerations dictate that trial participants be unblinded and those randomized to placebo be offered study vaccine, leading to trial protocol amendments specifying unblinding strategies. Crossover of placebo subjects to vaccine complicates inference on waning of VE.  We focus on the particular features of the Moderna trial and propose a statistical framework based on a potential outcomes formulation within which we develop methods for inference on potential waning of VE over time and estimation of VE at any post-vaccination time.  The framework clarifies assumptions made regarding individual- and population-level phenomena and acknowledges the possibility that subjects who are more or less likely to become infected may be crossed over to vaccine differentially over time. The principles of the of the framework adapted straightforwardly to other trials.

Internationally acclaimed biostatistician Dr. Marie Davidian is the J. Stuart Hunter Distinguished Professor of Statistics at North Carolina State University.

She has distinguished herself through her groundbreaking research focusing on the development of new statistical methods to support precision medicine discovery. She has dedicated her career to addressing emerging challenges in the health sciences while generously serving the statistical community and passionately mentoring the next generation of scientists in the field.

Highlights of Dr. Davidian’s honors and achievements:

  • 1998 Fellow, American Statistical Association
  • 2003 Myrto Lefkopoulou Distinguished Lectureship, Harvard T.H. Chan School of Public Health
  • 2005 Alumni Outstanding Research Award, North Carolina State University
  • 2006 Fellow, Institute of Mathematical Statistics
  • 2006 Fellow, American Association for the Advancement of Science
  • 2007 Janet L. Norwood Award for Outstanding Achievement by a Woman in the Statistical Sciences
  • 2009 George W. Snedecor Award, Committee of Presidents of Statistical Societies
  • 2010 Institute of Mathematical Statistics Medallion Lecturer and IMS Life Member
  • 2010 Alexander Quarles Holladay Medal for Excellence, North Carolina State University
  • 2011 Florence Nightingale David Award, Committee of Presidents of Statistical Societies
  • 2012 Presidential Invited Address, Spring Meeting, ENAR
  • 2012 D.D. Mason Award, Department of Statistics, North Carolina State University
  • 2012 International Biometric Society Award, Outstanding Contribution to the Development of the IBS
  • 2018 Honorary Life Membership, International Biometric Society
  • 2018 Founders Award, American Statistical Association
  • 2019 Snedecor Lecture, Iowa State University
  • 2019 Colin White Memorial Lecture, Yale School of Public Health
  • Executive Editor, Biometrics
  • President-Elect, 2012, President 2013 – American Statistical Association,
  • President-Elect 2003, President 2004 – ENAR of the International Biometric Society
  • Co-Founder/Organizer, Workshop for Junior Researchers, ENAR (2001 and 2002)
  • Principal Investigator for a total of 36 grants over two decades
  • Published 120+ peer reviewed articles
  • Author of 4 books, with 5th book Sample size calculations for SMARTs to be published later this year

About the Award

Marvin_ZelenThis annual award, supported by colleagues, friends and family, was established to honor Dr. Marvin Zelen’s long and distinguished career as a statistician and his major role in shaping the field of biostatistics.

The award recognizes an individual in government, industry, or academia, who by virtue of his/her outstanding leadership, has greatly impacted the theory and practice of statistical science. While individual accomplishments are considered, the most distinguishing criterion is the awardee’s contribution to the creation of an environment in which statistical science and its applications have flourished. The award recipient will deliver a virtual lecture on statistical science and will be presented with a citation and an honorarium.

Nominations

Nominations are welcome for next year’s award, to be given in May 2022.

Please send nominations via email

Nominations should include a letter describing the contributions of the candidate, specifically highlighting the criteria for the award, and a curriculum vita. Other supporting materials would be extremely helpful to the committee.

All nominations must be received by Friday, February 11, 2022.

Previous Award Winners

2020  Roderick J. Little
Missing Data Methods: Past, Present and Future

2019  Colin B. Begg
Challenges of Leading a Biostatistics Department in the 21st Century

2018  Constantine Gatsonis
The Evaluation of Diagnostic Imaging in the Era of Radiomics

2017  Richard Simon
Translating Genomics to Personalized Oncology: Key Contributions of Statistical Scientists

2016  Karen Bandeen-Roche
The Flourishing Statistical Environment: How can we tell?

2015  Nan M. Laird
DeSermonian and Laird on Meta-Analysis: Three Second

2014  Xiao-Li Meng
Personalized Treatment: Sounds Heavenly, But Where On Earth Did They Find the Right Guinea Pig For Me

2013  John J. Crowley
A Brief History of Survival Analysis

2012  Nicholas P. Jewell
Counting Civilian Casualties

2011  J.Richard Landis
Methods for Investigating Agreement & Concordance: with Applications in the Biomedical Sciences

2010  Ingram Olkin
Measures of Heterogeneity. Diversity and Inequality

2009  David L. DeMets
Challenges in Clinical Trials; Some Old and Some New

2008  Norman E. Breslow
The Case-Control Study: Origins, Modern Conception and Newly Available Methods of Analysis

2007  Scott L. Zeger
The Symbiosis of Statistical Science and Biomedicine; Past and Future

2006  Mitchell H. Gail
Absolute Risk: Clinical Applications and Controversies

2005  Ross L. Prentice
Chronic disease prevention: Research strategies and needs

2004  Robert C. Elston
The analysis of case-control data to detect candidate genes

2003  Wayne A. Fuller
Analytic studies with complex survey data

2002  Robert O’Neill
A Perspective on the Development and Future of Statistics at the FDA

2001  Niels Keiding
Event Histories and Their Analysis

2000  Lincoln E. Moses
Deciding whether Large Clinical Trials and Meta-analyses Agree or Not

1999  John W. Tukey 
A Smorgasbord of Handy Techniques That Can Help in Analyzing Data

1998  Sir David Roxbee Cox 
Graphical Models in Statistics: A Review

1997  Frederick Mosteller
The Importance of Clinical Trials in Education