Areas of Expertise

Expertise at N-Zero-1 covers a wide range of statistical solutions, from application of different statistical analysis methodologies, to report writing and teaching:

  • Statistical modeling, particularly mixed effects models.
  • Specialist Statistical methods for venous occlusion plethysmography and B-mode ultrasound measurement of carotid intima-media thickness.
  • All types of Simulation, for example to explore the dependency of sample size/power on uncertainties in the assumptions.
  • Survival methods (Kaplan-Meier, Cox Proportional Hazards model, accelerated failure time model).
  • Teaching statistics to non-statisticians.
  • DSMB/IRB membership.
  • Regulatory submissions, including briefing documents and regulatory defense.
  • Design & analysis of phase II/III clinical trials.
  • Preparation and review of clinical trial protocols, including objectives, design, endpoints, sample size/power, and statistical methods.
  • Writing Statistical Analysis Plans.
  • How to get more out of expensive data, by means of re-analyses, exploratory analyses, sensitivity and subgroup analyses.
  • Preparation and review of Clinical Study Reports and Integrated Summaries of Safety and Efficacy, making sure all statistical statements are accurate, supported by the data, and have the correct interpretation.
  • Preparation and review of manuscripts.
  • Graphical displays of statistical information.
  • Presentations of statistical information to Steering Committees, and Investigator Meetings.
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