Endpoint development to demonstrate safety and effectiveness.

Traditional Frequentist Methods

Adaptive Designs including Bayesian, Group Sequential (GS) and Sample Size Re-estimation (SSR)

Propensity Score Designs for non-randomized trials

Support FDA and other regulatory agencies submissions

Tables Listing and Figures (TLF)

Annual and Final reports, and Data Safety Monitoring Board (DSMB)

Provide statistical strategy and responding to inquiries from regulatory agencies

Resolve complex statistical regulatory issues in ongoing clinical trials

Represent and interact with regulatory bodies

Attend panel meetings, support research publications, and support investor focused projects