PROFESSIONAL PROFILE
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Creative, detail-oriented, and dedicated master’s level statistician & Certified Base SAS
programmer with extensive experience analyzing epidemiological, categorical, survival, survey
and census data.
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Highly skilled project leader leveraging exceptional analytical, communication, leadership and
organizational skills to analyze and interpret data.
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Outstanding skills focused on collection of project specifications, analysis of requirements and
testing and implementing new software applications.
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Trained by industry experts in protocol design, Good Clinical Practices (GCP), informed consent
procedures, Screening/Recruiting department processes, SOP’s (including 21CRF Part 11) and
drug development process during 12 years of pharmaceutical clinical research experience in
Phase-1 trials facility.
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Exceptionally strong ability to explain abstract technical and mathematical concepts.
CORE SKILLS
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Biostatistics for Observational Studies
Biostatistics for Clinical Trials
Survey Sampling
Database Development and Data Modeling
Internal Controls/Process Improvements
CDISC (ADaM and STDM)
Survival Analysis
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Experimental Design
Statistical Computing
Technical Writing
Spatial Statistical Analysis
System Process Development
Categorical Data Analysis
TECHNICAL PROFICIENCES
Languages
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SAS (4+ years)
S-Plus, R (3 years)
Pascal
Tools
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MS Office (DOC, XLS, PPT, MDB)
MS Project
ACT!
JMP Genomics
Michael O’Brien — Biostatistician & SAS Programmer
PROFESSIONAL EXPERIENCE
AESTUS THERAPEUTICS
North Brunswick, NJ
3/2010 — present
► Statistical Consultant
“Aestus Therapeutics is a translational medicine company focused on the accelerated development of firstin-class therapeutics for nervous system disorders.” (www.aestustherapeutics.com).
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Implement JMP Genomics (menu-driven version of SAS) for genomic data mining through
workflow evaluation and standardization (i.e. using JMP for data processing, QC and
consolidation). Establish, document and test unified workflow system for gene chip data
processing.
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Develop and modify software solutions within JMP for batch processing of gene expression data
(t-test, z-score, FDR) and conduct meta-analysis of data.
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Adapt JMP for cluster analysis using QT clustering and Tukey’s biweight analysis with graphic and
tabular annotation. Compare calculated correlations to flag disparate cluster correlation
calculations.
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Customize JMP Genomics by allowing rapid re-clustering visualization based on sample choice.
NOVO NORDISK
Princeton, NJ
08/2010 — 09/2010
► Sr. Biostatistician – HEOR (Diabetes Research), (Contractor through Kelly Services)
“Novo Nordisk is a focused healthcare company and a world leader in diabetes care.” (www.novonordisk-us.com)
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Conducted retrospective analysis of pharmaceutical claims data to examine the effect of cost on
incidence of compliance and rate of adverse events for different treatment regimens within
diabetic patient groups. Merged and queried large data sets (120 million + records) using SAS and
reduced the data sets based on inclusion/exclusion criteria. Accessed Thompson Reuters
MarketScan database and manipulated these data sets on UNIX server.
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Imported, queried, analyzed and reported data by using the following SAS modules: SAS/BASE,
SAS/STAT, SAS/MACRO, SAS/SQL and SAS/ODS. Tested, debugged and clearly documented final
code.
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Concatenated, merged, and transposed tables and used the following PROCS: Means, Summary,
Freq, Univariate, Report, Tabulate, Compare, Import, Export, IML and others.
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Michael O’Brien — Biostatistician & SAS Programmer
BRISTOL-MYERS SQUIBB CLINICAL PHARMACOLOGY UNIT (CPU)
Princeton, NJ (1997 – 1998), Hamilton, NJ (1998 – 2008)
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Senior Administrative Associate
Administrative Associate
Administrative Assistant
Office Coordinator, (Olsten Staffing Service)
05/1997 — 12/2008
05/2008 — 12/2008
06/1999 — 05/2008
07/1998 — 06/1999
05/1997 — 07/1998
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, oncology, cardiovascular and metabolic diseases. (www.bms.com)
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Compensated clinical trial participants through management of CPU checking account. Wrote
and distributed checks, transmitted electronic (EDI) data files, researched and generated referral
payments, resolved discrepancies with AP and General Accounting and compiled yearly earnings
for 1099 reports.
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Researched and resolved queries with data in Electronic Data Capture (EDC) system.
SAS PROGRAMMING / TRAINING
GRADUATE SCHOOL (RUTGERS UNIVERSITY)
New Brunswick, New Jersey
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09/2006 — 05/2009
Performed regression analysis (linear, non-linear, and multivariate), survival analysis, categorical
data analysis, logistic regression, ANOVA, and multivariate (principal component and cluster)
analysis in the following classes:
— Interpretation of Data: Imported data from Excel, Word and text-based data files into SAS
data sets. Wrote edit checks to remove invalid data. Analyzed survey and US Census data and
completed the following 3 projects:
1. (Project 1): Examined the impact of new housing projects on per-capita expenditures in
selected NY municipalities and made predictions on future expenditures using linear
regression.
2. (Project 2): Compared low-income housing in NJ to other US states using percentile plots and
summary statistics and performed linear regression on variables in each state.
3. (Project 3): Analyzed sales of orthopedic equipment by market segment using cluster
analysis and Principal Component analysis to reduce the dimensionality of the set of
variables.
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Michael O’Brien — Biostatistician & SAS Programmer
— Biostatistics 1 - An Introduction to Epidemiology: Conducted retrospective analysis of data
sets which included: finding confidence intervals by asymptotic methods, performing multiple
logistic and conditional logistic regressions, and evaluating fit of logistic models.
— Categorical Data Analysis: Manipulated contingency tables using Mantel-Haenszel test and
McNemar’s test. Explored Poisson regression models and generalized linear models.
— Life Data (Survival) Analysis: Performed calculations for Kaplan-Meier analysis, cumulative
hazard rates, probabilities of survival, finding the power of a test, accelerated life models and
proportional hazards models.
SAS INSTITUTE & OTHER CLASSES
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06/2009 — 05/2010
SAS Programming I – Essentials
SAS Programming II – Data Manipulation
SAS Programming III – Advanced Techniques and Efficiencies
SAS SQL I Essentials
— Applied knowledge of PROC SQL to perform match-merging, listing, reporting and to produce
subqueries.
SAS Macro Language I Essentials
Clinical SAS Programming
— Created clinical data tables, listings and figures (TLF’s), including patient demographics,
adverse events and laboratory baseline reports.
EDUCATIONAL BACKGROUND
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MS in Statistics (Biostatistics track), Rutgers University, New Brunswick, NJ, May 2009
BA in Mathematics, Rutgers University, New Brunswick, NJ, May 1991
Advanced SAS Certification – Anticipated in Spring 2011
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