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Data Administrative Assistant

Location:
South Brunswick Township, NJ
Posted:
December 01, 2012

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Resume:

MICHAEL O'BRIEN

* ****** ****

Kendall Park, NJ *8824

732-***-****

********@*******.***

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.)



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