Forrest Williamson
Baylor University
Fall 2012 Colloquium Series
Outline
 CROs: What are they and what do they do?
 CROs and Pharmaceutical Companies
 Independent Statistical Consulting
 Data Monitoring Committees (DMCs)
 Job Opportunities
 What did I do? (…no, really!)
 FDA
CROs: What are they and what
do they do?
CROs
 Contract Research Organization
 “A person or an organization (commercial, academic,
or other) contracted by the sponsor to perform one or
more of a sponsor's trial-related duties and functions.“
ICH-GCP (E6 1.20)
CROs and Pharmaceutical
Companies
Independent Consulting
 $20 billion / year
 Smaller pharma companies
 Study Design & Power
 Interim & Final Analyses
 Larger pharma companies
 Interim Analysis
 Randomization codes
DMCs / DSMBs
 Data Monitoring
Committee / Data Safety
Monitoring Board
 Members
 1 DMC chair
 3-4 physicians/
clinitians
 1-2 statisticians
DMC Open Sessions
 Sponsor allowed to
participate
 Updates on enrollment
and study status
 Explain interesting
medical events
 Justify statistical
methods chosen
 Look at all enrolled
patients
DMC Closed Sessions
 Sponsor kicked out!
 Information given per
treatment arm
 DMC members look for
unusual events,
differences between
treatment arms
 Must make a suggestion
to the sponsor to
continue/ discontinue
the study
DMC Report – closed version
Job Opportunities
(Bio)statistician
Clinical
Non-Clinical
 Study Management
 Modeling & Inference
 Training programmers
 Design
 Data enhancement
 Research
 Emergency unblinding
 Outside training
 Hosting DMCs
 Simulations
Statistical Programmer
 Creating analysis
datasets
 Programming DMC
report elements (TLFs)
 Performing statistical
tests
 SAS 
What did I do?
Tester
 Quality control on DMC
report elements
 Check programmer’s
results with independent
code
 Organize final reports
 Buffer between
statisticians and
programmers
What the heck, FDA?!
FIN