Statistical Programmer Resume Example Fast Track Drugs And Biologics

STATISTICAL PROGRAMMER

Summary

Will be relocating to Phoenix, AZ.

SAS programmer in pharmaceutical industry since 2007.

Experience analyzing data and producing tables.

Highlights

Education

SAS Certification:October 2007

Bachelor of Science:Mathematical Sciences,May 2007Loyola College in Maryland Loyola University Maryland － Baltimore, MD

Experience

Statistical Programmer, 04/2011 to CurrentFast 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 04/2011Teva 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 08/2010C-TASC － Owings Mills, MD

Biostatistician, 09/2007 to 09/2009Sucampo 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 09/2006FDA － Rockville, MD

Reviewed vaccine submissions approved 2001 to 2006 and compiled data on pivotal studies and their design.

Additional Training

Additional SAS Courses

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.

Resume Overview

Companies Worked For:

School Attended

Job Titles Held:

Degrees

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