Vaccines SIG


  • To create a professional platform for statisticians in the Pharmaceutical industry, Regulatory agencies and Public Health organizations working on the research and development of vaccines to understand how best to apply methodologies.
  • To keep up-to-date, discuss, apply and encourage relevant statistical and methodological developments. 
  • To encourage professional development. 
  • To organise (web)seminars and sessions in worldwide conferences on topics related to methodological developments in vaccines research.

Who we are

  • Holly Janes, Fred Hutchinson Cancer Research Center, USA.
  • An Vandebosch, Johnson & Johnson, Belgium
  • David Radley, Pfizer, USA.
  • Fabian Tibaldi, GlaxoSmithKline Vaccines, Belgium.
  • Frank Liu,Merck Sharp & Dohme corp., USA
  • Tsai-Lien Lin, FDA, USA.
  • Scott Patterson, Sanofi Pasteur, USA.
  • Fabrice Bailleux, Sanofi Pasteur, France
  • Larry Moulton, Johns Hopkins Bloomberg School of Public Health, USA

How to get in touch

If you have an interest in being involved in this SIG, or have an interesting case study or experience to share please contact Fabian Tibaldi (email:

Latest News

Special issue of the Statistics in Biopharmaceutical Research dedicated to Vaccines and Biologics

The editorial board of the Statistics in Biopharmaceutical Research (SBR) journal plans to publish a special issue on Vaccines and Biologics. The special issue is motivated by the recognition that there are many unique statistical issues and challenges in vaccines and biologics development arising from the complex biological nature of these two classes of therapeutic products . The special issue seeks to publish high quality manuscripts focused on innovative approaches and reviews related to the statistical design, modeling and analysis of clinical and nonclinical studies of vaccines and biologics. Innovative statistical designs in clinical trials, statistical approaches to biosimilarity, especially as relating to regulatory considerations and reviews of the literature are especially welcome, although a broad range of statistical topics is anticipated.

Timelines and submission instructions for the special Vaccines and Biologics issue of the SBR:

1. The window for submission will be November 1, 2019 – June 30, 2019. Submissions are made through the SBR portal. 
2. At the time of the submission of the manuscript, authors are asked to check the VB2019 selection box at Step 1 on the submission page, so the manuscript will be designated for the 2019 Vaccines and Biologics special issue.
3. Manuscripts will go through the standard SBR refereeing process.
4. Goal is to have a set of papers ready for publication in late 2020.

We appreciate your consideration and contributions to make the special issue of the SBR a showcase for cutting edge statistical methods and applications on vaccines and biologics.

Upcoming Events

Invited vaccine session at

ISBS, Kyoto, Japan, August 26-30, 2019.

Statistical Issues and Methods for Vaccine Development

Organizer: Frank Liu and Jie Chen

Chair:  Frank Liu


Because of biological nature, there are many unique statistical issues and challenges in vaccine development. Some examples are: the rigorous safety requirement because vaccines are to be administrated to millions of healthy individuals; large studies needed to demonstrate efficacy due to low incidence rate of disease and strict requirement on a positive lower bound to show adequate efficacy; identifying and using biomarkers based on correlates of protection; dealing with uncertainty of event rates; and non-inferiority and lot consistency trials. In this session, speakers from industry and academia will talk about some of those unique features and challenges in design and analysis of vaccine trials, and share advances in statistical methods for handling the issues.

Invited speakers and tentative titles:

  1. Holly Janes, Fred Hutch, Seattle, WA, USA,  “Potential HIV vaccine efficacy trial designs in the era of an expanding portfolio of non-vaccine HIV prevention strategies”
  2. Jing Jin, Sanofi, Beijing, China, “Immune correlates analysis of tetravalent dengue vaccine efficacy trials”
  3. Wenji Pu, GSK, Rockville, MD, USA, “Application of Bayesian Statistics in Vaccine Clinical Trials”
  4. Bart Spiessens, Janssen, Belgium, “Statistical challenges of an immune-bridging approach to assess clinical benefit as the basis for licensure of a prophylactic Ebola vaccine”

Discussant: Wenquan Wang, Sanofi Pasteur, Swiftwater, PA, USA.


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EventsFuture Events

  • A PSI Training Course on Improving Influence and Increasing Impact: Communication Skills for Industry Statisticians - Dates: 16 – 16 Sep, 2019

    This 1-day course will lead participants, in a non-threatening and encouraging atmosphere through steps to focus on improving the key skills of making impactful verbal and written communications.
  • PSI Webinar: Adaptive design: updated draft FDA guidance and its implications - Dates: 04 – 04 Jul, 2019

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
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