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Last update of this page: 18th May 2026.

I have a strong biostatistical background and a deep understanding of clinical research, regulatory environments, and the product development lifecycle within life sciences. I am passionate about applying this expertise to solve problems in pharmaceutical drug development.

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I am an Accredited European Statistician, a qualification issued by The Federation of European National Statistical Societies.

I am a member of the ICH E20 expert writing group as a deputy topic lead, representing EFPIA.

I see me supporting statisticians and drug developers to continuously challenge the status quo, with the aim of improving the drug development process, making it more efficient, and enabling access. To achieve this, I believe that an attitude and mindset of

  • integrity,
  • teamwork,
  • scientific rigour,
  • solid understanding of statistical methodology,
  • a genuine desire to collaborate beyond organizational boundaries (both within and across companies, with regulators, and with academics),
  • and an insatiable curiosity

are essential.

I have a reputation of getting things done.

Key achievements in my career:

  • Built global network among statisticians in drug development, i.e. industry, regulators, and academia.
  • Biostatistics or biometrics lead for filings of oncology and fertility drugs.
  • Designed, ran, analyzed, and discussed with regulators various early and late phase clinical trials.
  • At both Roche and Merck, co-developed and rolled-out quantitative decision-making framework in R&D.
  • Co-founded and co-lead X-industry working groups with global impact: Oncology estimand WG, EFSPI statistical methodology leaders group, SAVVY.
  • Chair (3x) and member of Scientific Committee (since 2017) of organizing committee of EFSPI regulatory statistics workshop.
  • Co-chair of ISCB46 2026 in Basel (global statistics conference with >850 attendees).
  • Member of ICH E20 expert writing group.
  • Giving many courses for statisticians and non-statisticians on many levels.
  • Initiated and teaching regular course series on statistical and quantitative topics for non-statisticians with 100s of regular attendees at Roche and Merck.
  • Supervised or co-supervised one PhD and ten MSc thesis.
  • More than 100 scientific papers, many of them in top statistical or medical journals.
  • Written or co-written 15 R packages on CRAN.
  • Statistical methods to optimize clinical trial designs
  • Advanced survival analysis
  • Probability of success
  • Estimands and causal inference
  • Nonparametric statistics

Kaspar Rufibach is a biostatistician who is passionate about supporting statisticians and drug developers to continuously challenge the status quo, with the aim of improving the drug development process, making it more efficient, and enabling access.

Kaspar has co-founded and co-leads the special interest group Estimands in oncology which has (as of August 2024) more than 100 members from 50 institutions globally. He has also co-founded and co-leads the EFSPI statistical methodology leader group which has 16 members from 16 companies. He regularly interacts with regulators globally on various joint projects.

Kaspar’s research interests are methods to optimize study designs, platform trials, advanced survival analysis, probability of success, estimands and causal inference, and estimation of treatment effects in subgroups.

Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich. During his PhD he gained some first experience in clinical research as a part-time statistician at the Swiss Institute for Applied Cancer Research. From 2012 until 2024 he worked at Roche in Basel before joining Merck KGaA in October 2024 (100% home-based) to co-lead its Advanced Biostatistical Science group.