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He is currently employed with a CRO, and has worked in the Pharmaceutical Industry for over 23 years. Good knowledge of statistics and statistical programming. Experience in writing and reviewing requirements and also reviewing SAPs and Protocols.
EDUCATION
2000 MS, Statistics
University of Kentucky
Lexington, Kentucky USA
1980 BS, Mathematics
Marymount College
Salina, Kansas USA
PROFESSIONAL EXPERIENCE
.
Jan 2014 to present Lead Statistical Programmer Analyst
Navitas Life Science
Pottstown, Pennsylvania, USA
Program ADaM datasets
Create requirements for ADaM datasets
Create mocks
Program TFL programs
Program SDTM datasets
Oct 2010 to Dec 2014 Senior Statistical Programmer
inVentiv Health Clinical
Indianapolis, Indiana USA
Reviewing CRF, SAPs, Protocols,
Developing ADS requirements
Working on ADS QR
Writing TFL requirements
Writing SAS programs as per requirements
Validating SAS programs
Core member of a Six Sigma team
PROFESSIONAL EXPERIENCE, CONTINUED
Mar 2002 to Oct 2010 Statistical Analyst
Eli Lilly & Co.
Indianapolis, Indiana USA
Oversaw outsourcing activities to a TPO concerning TFL delivery
Reviewed CRF, SAPs, Protocols,
Developed ADS requirements
Wrote TFL requirements
Wrote SAS programs as per requirements
Validated SAS programs
Core member of a Six Sigma team
Site Steward for Stats collaboration site
.SharePoint SME
Wrote and supported the code for the ARC tool
July 2001 to Mar 2002 Statistical Programmer
Pfizer Inc.
Groton, Connecticut USA
Prepared reports for stability of compounds and material properties, using Quality Control methods, employing SAS and Splus using statistical procedures such as PROC MIXED, or variance components
Jun 2000 to Jun 2001 Statistical Programmer
Merck & Co.
West Point, Pennsylvania USA
Prepared reports for stability of compounds, expiry dating, % degradates, % label claim assay, weight uniformity, and content uniformity utilizing SAS, Splus, and R.
PROFESSIONAL MEMBERSHIPS
2004- Present Toastmasters International
FOREIGN LANGUAGES
Spanish Speak and Read
Japanese Read (not Kanji) Speak at a low level
SUMMARY OF PROJECT EXPERIENCE
Therapeutic Area, Sub Indication and Drug Class
Phase
Job Title
Neuroscience
I-III
Senior Statistical Programmer
Oncology
I-III
Senior Statistical Programmer
Biomedicine
I-III
Senior Statistical Programmer
Diabetes
I-III
Senior Statistical Programmer
PUBLICATIONS/PRESENTATIONS
Midwest Biopharmaceutical Workshop Muncie, Indiana
Using Numbers Needed to Treat in a Study of Major Depressive Disorder
Midwest Biopharmaceutical Workshop Muncie, Indiana
Comparison of Scenarios in Choosing a Covariance Structure in a Longitudinal Depression Trial with Missing Data
Eli Lilly Global Statistical Science w/ Karen Price
Estimation of Total Patient Exposures Using Post-Marketing Data
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