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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