Biostatistician in Central NJ Resume Michael O'Brien by MichaelOBrien4


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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.

      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               Experimental Design
      Biostatistics for Clinical Trials                     Statistical Computing
      Survey Sampling                                       Technical Writing
      Database Development and Data Modeling                Spatial Statistical Analysis
      Internal Controls/Process Improvements                System Process Development
      CDISC (ADaM and STDM)                                 Categorical Data Analysis
      Survival Analysis

Languages                                                 Tools

      SAS (4+ years)                                        MS Office (DOC, XLS, PPT, MDB)
      S-Plus, R (3 years)                                   MS Project
      Pascal                                                ACT!
                                                             JMP Genomics
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                                 Michael O’Brien — Biostatistician & SAS Programmer

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

      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

      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 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.

      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

      Concatenated, merged, and transposed tables and used the following PROCS: Means, Summary,
       Freq, Univariate, Report, Tabulate, Compare, Import, Export, IML and others.

                                               Page 2 of 4
                                  Michael O’Brien — Biostatistician & SAS Programmer

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

           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

                                                Page 3 of 4
                                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                                                        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
      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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