MICHAEL O'BRIEN
Kendall Park, NJ *8824
********@*******.***
Biostatistics for Observational Studies
Categorical Data Analysis
Excel, Word and text-based data files into SAS data sets. Wrote edit checks to clean
invalid data from
SAS/ODS.
survival analysis, categorical data analysis, logistic regression, ANOVA, and
multivariate analysis
Freq, Univariate, Report, Tabulate, Compare, Import, Export, IML and many others.
academic environment. Skilled project leader utilizing excellent analytical,
communication,
laboratory baseline reports, using shell scripts as guides. Used SAS/GRAPH to draw
graphs.
queries. Used hash and hiter objects with indexes to reference data more efficiently in
look-up tables.
database. Tested code and debugged against the test data and actual data. Clearly
documented final
Biostatistics for Clinical Trials
Survival Analysis
(principal component and cluster analysis).
leadership and organizational skills to analyze and interpret data. Ability to collect
project
code.
Learned clinical data structures (C-DISC) and STDM, variable prefixes, domain
structures and
Survey Sampling
Experimental Design
specifications, analyze requirements and test and implement new software applications.
standards.
Database Development and Data
Statistical Computing
Received training in protocol design, Good Clinical Practices (GCP), informed consent
Modeling
procedures, Screening/Recruiting department processes, SOP s (including 21CRF Part 11)
and
Technical Writing
the drug development process during 12 years of pharmaceutical clinical research
experience in
Internal Controls and Process
Spatial Statistical Analysis
a Phase-1 trials facility
Improvements
System Process Development
Written/Oral Communication Skills
A
CLINICAL SAS PROGRAMMER
Creative and dedicated master s level statistician and certified Base SAS programmer
with
REAS OF E XPERTISE :
SAS PROGRAMMING EXPERIENCE
Applied SAS for 4 years in a PC environment.
Applied SAS to importing, pre-processing, querying, analyzing and reporting data.
Imported data from
Demonstrated experience in SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/MACRO, SAS/SQL and
Adapted SAS/STAT procedures to do regression analysis (linear, non-linear, and
multivariate),
Concatenated, merged, and transposed tables an d used the following
PROCS:
Means,
Summary,
experience analyzing epidemiological, categorical, survival, survey and census data in an
Created clinical data tables, reports and listings, including patient demographics,
adverse events and
Applied knowledge of PROC SQL to perform match-merging, listing, reporting and to
produce sub-
MICHAEL O'BRIEN Page 2
EDUCATIONAL BACKGROUND
MS
in Statistics (Biostatistics tract), Rutgers University, New Brunswick, NJ, May
2009
BA
in Mathematics, Rutgers University, New Brunswick, NJ, May 1991
Advanced SAS Certification Anticipated in Summer 2010
TECHNICAL PROFICIENCIES
Languages:
SAS (4 years), S-Plus, R (3 years), Pascal
Tools:
Proficient in (MS Word, Excel, PowerPoint, Access), MS Project, Internet Explorer, E-
mail, ACT!
PROFESSIONAL EXPERIENCE
BRISTOL-MYERS SQUIBB CLINICAL PHARMACOLOGY UNIT
)
Bristol-Myers Squibb is a $20 billion biopharmaceutical company with over 30,000
employees worldwide.
The CPU was a phase-1 clinical research facility for testing investigational drugs on a
healthy human
population. We administered approximately 15-20 protocols a year, each comprised of
multiple,
overlapping groups of 8-24 subjects each, in multiple therapeutic areas including
dermatology,
neuroscience, immunology, anti-infective, onco logy, cardiovascular and metabolic
diseases.
Senior Administrative Associate, 05/200812/2008
Administrative Associate, 06/199905/2008
Administrative Assistant, 07/199806/1999
Office Coordinator, 05/199707/1998 (contractor - Olsten Staffing Service)
Compensated clinical trial participants through the management of the CPU checking
account. Duties
included writing and distributing checks, sending electronic (EDI) data files,
researching and generating
referral payments, placing stop payments, coordinat ing with bank to ensure sufficient
funds, and
compiling yearly earnings for 1099 reports. Increa sed the efficiency of the CPU check
system by
facilitating the conversion to a new checking account software application and making the
upgrades
compliant with our computer network. Ensured pr oper use of the new check software by
writing a
procedures manual for the new system and training at least six co-workers.
Entered study data into Electronic Data Capture (EDC ) system. Used TAO (Trial Access
Online) software
to enter data from written case report forms into electronic case report forms. Also,
verified correct entry
of laboratory data into TAO by LIMS system. Researched and resolv ed queries with data by
determining
whether they were transcription or data entry er rors and then correcting the data values
in TAO.
Kept studies effectively on schedule by preparing documents for monthly meetings of
Institutional Review
Board (I.R.B.)