Dr Kevin J Carroll is a chartered professional statistician with more than 24 years’ experience in clinical trials and drug development. He was formerly VP Statistics and Chief Statistician at AstraZeneca pharmaceuticals and Expert Statistician at Boehringer-Ingelheim. His experience spans all phases of development and multiple therapeutic areas including Oncology and Cardiovascular. Kevin has a Master’s in Applied Statistics with Distinction from Sheffield Hallam University and is currently a Senior Honorary Lecturer in Medical Statistics at the University of Sheffield.

During his career, Kevin has managed a large team of statisticians, programmers and data managers to deliver multiple new drug license applications. Further, he developed, published and applied innovative, novel statistical methodologies and gained hands on experience in the application of adaptive and Bayesian approaches to trial design and analysis. Kevin also has deep experience liaising with regulatory agencies world-wide on drug development issues including the US Food and Drug Administration (FDA), the European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare. This includes unique experiences as a key presenter at several FDA Advisory Committees.

Years of Experience

24 years’ drug development experience as a pharmaceutical industry statistician.

Key Experience

  • Senior R&D Governance experience and development of statistical strategies to support efficient drug development programmes.
  • Delivery of multiple new drug applications and leadership of biometric teams.
  • Extensive experience interacting with regulatory agencies world-wide, including unique FDA Advisory Committee and EMA CHMP Oral Hearing experiences.
  • Development and delivery of training courses in medical statistics.

Previous Roles

  • VP Statistics and Chief Statistician, AstraZeneca Pharmaceuticals (October 1989 – July 2012)
  • Senior Director Statistical Consulting, BoydConsultants (August 2012 – December 2012)
  • Expert Statistician, Boehringer-Ingelheim (December 2012 – December 2013)

Qualifications and Professional Body Membership

  • Chartered Statistician, Royal Statistical Society
  • Chartered Scientist, UK Science Council
  • PhD from University of East Anglia, UK: “Statistical issues in oncologic clinical drug development”
  • M.Sc. in Statistics with Distinction and Prize for Best Overall Performance, Sheffield Hallam University
  • B.Sc. in Mathematics and Statistics, First Class, Leeds University
  • Board of Directors, PSI (Statisticians in the Pharmaceutical Industry)
  • Council Member, EFPSI (European Federation of Statisticians in the Pharmaceutical Industry)