Bittman Biostat, Inc.

Statistical Consulting for Pharmaceutical & Device Development   

Home About Case studies
Services for product development Services to the legal profession


Services for product development

Develop and execute clinical trials
  Protocol design: sample size, power, interim analysis, statistical methods
  Modeling of clinical trial outcome scenarios
  Randomization schedules
  Statistical Analysis Plan: prepare methods, mock tables and graphs
  Programming for analysis tables, listings, figures and statistical reports
Lead Data Safety Monitoring Boards (DSMBs) and data
coordinating groups
  Serve as DSMB Chair
  Head the unblinded data coordinating group
  Write charters
Join sponsor in regulatory interaction
  Pre-IND, End of Phase 2, pre-submission meetings
  NDA/BLA/PMA preparation

Responses to queries and critiques

  Advisory Committee preparation
Work with CEOs and CFOs

Due diligence evaluation of in-licensing or defense of out-licensing candidates

  Clinical trial outcome scenarios for investment decisions
  Relationship management with contract research organizations
  Vendor proposal and budget assessment
Strengthen client’s infrastructure

Write statistical Standard Operating Procedures (SOPs)

  Statistical software validation
  Peer review and independent verification of results
Design non-clinical experiments (DOE)

Stability (shelf-life)

  Process and yield optimization
  Comparability studies
  Formulation development
  Assay validation
Optimize client benefit from vendors

Provide statistical specifications for randomizations, Interactive Voice
Response Systems and electronic diaries

  Review vendor deliverables
Provide other targeted solutions

Serve on mock Advisory Committee and Dispute resolution panels

  Data analysis for manuscripts and presentations
  Exploratory data analysis, post-hoc and meta-analyses
  Statistical method development



Dr. Richard M. Bittman
9047 Cherry Oaks Trail #202
Naples, Florida 34114

Phone: 239.970.0536