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.
  • Allen Izu,GlaxoSmithKline Vaccines, 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.

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

A Newsletter including important information related to conferences, published papers and other scientific activities will be issue earlier 2019.

Latest News

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EventsFuture Events

  • PSI Toxicology SIG Workshop 2019 - Dates: 02 – 03 Apr, 2019

    This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.​
  • PSI Journal Club: Missing Data - Dates: 24 – 24 Jan, 2019

    Our next journal club, held jointly with the DIA, features two papers on the topic of Statistical Considerations for Innovative Designs in Clinical Trials. Please join us to hear Jason Yuan and Xiangmin Zhang present their recent work.

Principal Statistician


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Senior/Principal Biostatistician



Statistician for HTA/Medical Affairs (contractor and permanent)



Associate / Senior / Principal Statistical Scientist positions