Michael O’Brien — Biostatistician SAS Programmer

  • Creative, detail-oriented, and dedicated master’s level statistician & Certified Base SAS programmer with extensive experience analyzing epidemiological, categorical, survival, survey and census data.
  • Highly skilled project leader leveraging exceptional analytical, communication, leadership and organizational skills to analyze and interpret data.
  • Outstanding skills focused on collection of project specifications, analysis of requirements and testing and implementing new software applications.
  • 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.
  • Exceptionally strong ability to explain abstract technical and mathematical concepts.
  • 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
/
  • Experimental Design
  • Statistical Computing
  • Technical Writing
  • Spatial Statistical Analysis
  • System Process Development
  • Categorical Data Analysis

Languages / Tools
  • SAS (4+ years)
  • S-Plus, R (3 years)
  • Pascal
/
  • MS Office (DOC, XLS, PPT, MDB)
  • MS Project
  • ACT!
  • JMP Genomics

AESTUS THERAPEUTICS / 3/2010 — present
North Brunswick, NJ
► Statistical Consultant
“Aestus Therapeutics is a translational medicine company focused on the accelerated development of first-in-class therapeutics for nervous system disorders.” ().
  • 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.
  • 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.
  • 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.
  • Customize JMP Genomics by allowing rapid re-clustering visualization based on sample choice.

NOVO NORDISK / 08/2010 — 09/2010
Princeton, NJ
► Sr. Biostatistician – HEOR (Diabetes Research), (Contractor through Kelly Services)
“Novo Nordisk is a focused healthcare company and a world leader in diabetes care.” ()
  • Conducted retrospective analysis of pharmaceutical claims data to examine the effect of cost on incidence of compliance and rate of adverse eventsfor differenttreatment regimenswithin 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.
  • 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.
  • Concatenated, merged, and transposed tables and used the following PROCS: Means, Summary, Freq, Univariate, Report, Tabulate, Compare, Import, Export, IML and others.

BRISTOL-MYERS SQUIBB CLINICAL PHARMACOLOGY UNIT (CPU) / 05/1997 — 12/2008
Princeton, NJ (1997 – 1998), Hamilton, NJ (1998 – 2008)
► Senior Administrative Associate / 05/2008 — 12/2008
► Administrative Associate / 06/1999 — 05/2008
► Administrative Assistant / 07/1998 — 06/1999
► Office Coordinator, (Olsten Staffing Service) / 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. ()
  • 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.
  • Researched and resolved queries with data in Electronic Data Capture (EDC) system.
GRADUATE SCHOOL (RUTGERS UNIVERSITY) / 09/2006 — 05/2009
New Brunswick, New Jersey
  • 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.
  1. (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.
  1. (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.

—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 / 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.

  • 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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