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Fast Track Drugs and Biologics - Statistical Programmer Resume Example

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STATISTICAL PROGRAMMER
Summary

Will be relocating to Phoenix, AZ.

SAS programmer in pharmaceutical industry since 2007.

Experience analyzing data and producing tables.

Highlights
  • 5 years of SAS programming experience
  • Advanced Microsoft Excel and Access skills
  • Training in Good Clinical Practice
  • Statistical analysis and database experience
  • SQL knowledge
  • Excellent communication skills
Education
SAS Certification: October 2007
Bachelor of Science: Mathematical Sciences, May 2007 Loyola College in Maryland Loyola University Maryland － Baltimore, MD
Experience
Statistical Programmer, 04/2011 to Current Fast Track Drugs and Biologics － North Potomac, MD
  • Performed analyses of clinical trials for treatment of skin disease and alcoholism.
  • Produced tables and listings of safety and efficacy results.
  • Produced monthly reports of safety for ongoing trials.
  • Mapped clinical trial datasets to comply with CDISC Study Data Tabulation Model (SDTM) standards. (Produced specifications, transformed data in SAS, produced datasets for internal review and adjusted programs based on comments received, and validated datasets.)
Consultant Statistical Programmer, 08/2010 to 04/2011 Teva Pharmaceuticals － Horsham, PA
  • Acted as lead programmer producing tables, listings, and analysis datasets for asthma clinical study.
  • Cooperated with other programmers to validate tables and datasets.
  • Reviewed dataset specifications for consistency with CDISC SDTM.
  • Created macros to do complex manipulations and analysis of PK datasets.
SAS Programmer, 09/2009 to 08/2010 C-TASC － Owings Mills, MD
  • Used SAS and CDISC knowledge to map legacy datasets.
  • Reviewed results of SQL programming.
  • Worked with SQL programmers to revise queries.
Biostatistician, 09/2007 to 09/2009 Sucampo Pharmaceuticals － Bethesda, MD
  • Provided statistical and SAS programming support for clinical trials.
  • Combined data from multiple studies.
  • Wrote SDTM and Analysis Data Model (ADaM) specifications, statistical analysis plans (SAPs), and mock tables, figures, and listings.
  • Made revisions to specifications and plans after review, maintaining the documents, and keeping track of changes to communicate to other programmers and statisticians.
  • Performed quality control programming based on the SAP to verify analysis populations, unblinding, and complex efficacy endpoints.
  • Communicated with outside contract programmer to validate results.
  • Provided further analysis as requested by FDA after submission.
  • Carried out new analyses on past studies and designed tables to display information.
Office Automation Clerk, 05/2006 to 09/2006 FDA － Rockville, MD
  • Reviewed vaccine submissions approved 2001 to 2006 and compiled data on pivotal studies and their design.
Additional Training

Additional SAS Courses

  • SAS Programming 3: Advanced Techniques and Efficiencies
  • Macro Language 1: Essentials

Conferences:

  • Joint Statistical Meetings (JSM) in 2007 and 2009
  • Pharmaceutical Industry SAS Group conference (PharmaSUG) in 2008 DIA/FDA CDER/CBER Computational Science Annual Meeting March 22-23 2010
  • PhUSE/FDA Computation Science Symposium March 2013
  • Poster presentation at Digestive Diseases Week (DDW) in 2009 Effect of Stool Consistency on Outcome in Subjects with Irritable Bowel Syndrome with Constipation: Analysis of Three Randomized Studies with Lubiprostone.
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Resume Overview

Companies Worked For:

School Attended

  • Loyola College in Maryland Loyola University Maryland

Job Titles Held:

  • Statistical Programmer
  • Consultant Statistical Programmer
  • SAS Programmer
  • Biostatistician
  • Office Automation Clerk

Degrees

  • SAS Certification : October 2007
    Bachelor of Science : Mathematical Sciences , May 2007

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