EXECUTIVE SUMMARY:
I am a Senior SAS Statistical Programmer Analyst with 24 years
IT experience and 7 years experience in programming and system
development for pharmaceutical clinical trials (Phase I, II,
and III). I have performed advanced statistical programming
utilizing Base SAS, SAS Statistical Procedures, and SAS Macros.
I have also developed UNIX Korn Shell scripts to facilitate the
statistical programming process. I frequently generate Safety
Tables and Listings for Phase II and III Clinical Study Reports.
I have also worked on ISS & ISE studies. I have performed
extensive work on Table and Listing computer system validation
(i.e., gathering user requirements, creation of functional
specifications, design specifications, test plan development,
gap analysis, and risk assessments). Most recently I generated
tables, listings, and CDISC SDTM datasets for a Phase I study.
I have performed SAS program problem tracking, SAS program
metrics, QC, and SAS program change management. I have
performed code review of SAS programs and UNIX KornShell
scripts. I frequently assist my peers in the development of
Tables, Listings, and Analysis Data Set creation. I am a strong communicator
that works well in a team environment and I enjoy
training fellow members of my team.
EDUCATION:
Associate of Science, Computer Programming Technology
Indiana Vocational Technical College, Terre Haute, IN
August 1984
Biology
Indiana State University, Terre Haute, IN
Fall 1977 – Spring 1980
SKILLS:
SAS Programming: Base SAS, SAS Procedures (including proc
SQL), SAS Macros, and PC SAS
Additional Programming: KornShell scripts, COBOL, Assembler, and
PL/1
Software: MS Office, Lotus Notes, Revision Control
System (RCS)
Operating Systems: UNIX, MVS, VSAM , VM, VAX, MS Windows
Databases: DB2
Miscellaneous: Remote SAS Server, Reflection, FTP, TSO,
ISPF, JES2, JCL, Syncsort, IBM Mainframe
(MVS/XA and ESA), Client/Server, NT
Servers, Xpediter, Fileaid, Panvalet,
Champ, Infoman, Changeman, CMS,
VTAM/TPX, Omegamon, Easytrieve(EZtrieve),
SDSF, VPS, TMS, Roscoe, CA7, Control/M,
CICS, IMS
EXPERIENCE:
ASG, Inc. Consulting Statistical Programmer Quintiles,
Overland Park, KS
July 2008 to November 2008
Create Phase I SDTM analysis datasets based on CDISC SDTM
Implementation Guide (SDS Version 3.1)
Create Phase I Safety Tables and Listings for multiple
customers
Create Data Definition Tables for multiple studies
Perform QC for Listings as needed
Identify macro coding errors as needed
Identify source data errors as needed
Senior Statistical Programmer Analyst for Allergan Inc,
Irvine, CA
November 2004 to April 2008
Biostatistics and Statistical Programming Technical
Representative for the development and maintenance of
software systems for statistical applications. Primary area
of responsibility is the Standard Reporting System (SRS).
The SRS is designed to integrate SAS programs, SAS macros,
UNIX Korn Shell scripts, SRS initialization files, and SRS
configuration files. The function of the SRS is to automate
the production of standard Safety Tables and Listings for
inclusion in Clinical Study Reports (CSR).
Assist team members in the production of Analysis Data Sets
and Tables and Listings for their assigned studies.
Adverse Event by System Organ Class, Demographics,
Disposition, Lab Change from Baseline, Medical History, and
Vital Signs, are a few of the modules currently standardized
in the production system. The SRS is capable of producing
over 100 Tables and Listings.
Prepare electronic approval Computer System Validation
documents such as Risk Assessment, User Requirements
Specification, Design Specification, Traceability Matrix, and
Test Plans for Installation, Operation, and Performance
Qualification to ensure systems are properly validated.
Manage the System Development Life Cycle for the Standard
Reporting System.
Maintain SRS issue tracking with short term and long term
mitigation measures designed for continuous process
improvement.
Complete SAS Institute training for the Advanced SAS
Programming Library.
Submit change requests for bug fixes and system enhancements.
Perform Code Review of SAS programs, macros, and UNIX Korn
Shell scripts.
Create Standard Operating Procedures, Work Instruction
Manuals, User Manuals, User Exercises, Developer Guides,
and Developer Checklists.
Create randomization data sets for clinical studies.
Assist other teams in Biostatistics and Statistical
Programming as needed.
ASG, Inc. Consulting Statistical Programmer Allergan, Irvine, CA
December 2003 to November 2004
Participate in the creation of a User Manual for the Standard
Reporting System. The SRS is a collection of SAS programs,
SAS macros, and UNIX Korn Shell scripts designed to produce
Safety Tables and Listings.
Perform UNIX Korn Shell script code review and provide UNIX
assistance to peers.
Perform SAS macro code review.
Review of analysis data set templates vs. database lock
dataset specifications.
Created test analysis data sets for user exercises.
ASG, Inc. Consulting Clinical SAS Programmer Scios, Fremont, CA
August 2003 to November 2003
Performed SAS macro validation and peer review using Windows
NT PC SAS.
Created validation test data.
KFORCE Consulting SAS Programmer Analyst Eli Lilly and Company,
Indianapolis, IN
September 2001 to April 2003
Perform problem analysis on new metadata load system for the
creation of analysis data sets for Phase I, II, & III clinical
trials.
Produce statistical Tables and Listings for Oncology drug
NDA (Alimta).
Perform ISS & ISE validation, problem analysis, and code
modification.
SAS macro development, modification, and problem analysis for
clinical study reports.
Assist Decision Support Analysts in the development of
metadata files.
Perform system validation of report macros.
Ensure change requests and associated documentation is
21 CFR Part 11 compliant.
KFORCE Consulting SAS Programmer at Eli Lilly and Company,
Indianapolis, IN
April 2001 to September 2001
Technical Lead for development of a new metadata load system
which creates analysis datasets for Phase I, II, & III
clinical trials.
Guidance of fellow team members, SAS macro development, and
code peer review.
Programmer Analyst at First Tennessee Bank in Louisville,
Kentucky
November 2000 to April 2001
Analyzed customer transmission files from Memphis.
Analyzed and modified COBOL programs to identify transmission
file formats.
Served as liaison for the Data Center Migration.
System Administrator
U.S. Census Bureau Processing Center in Jeffersonville, Indiana
January 2000 to November 2000
System administration of Windows NT Client/Servers for the
Census Bureau National Processing Center in Jeffersonville, IN.
Configuration of NT servers and client workstations.
Electronic Data Systems
April 1985 to November 1999
Information Analyst
Worked on Y2K project and analyzed PL/1 DB2 programs for
possible Y2K exposures. Developed test cases, performed
testing, and peer review.
Converted COBOL Transform programs into structured COBOL.
Developed testing guidelines for ensuring all required program
functions were retained. Worked with IMS DB/DC online
transaction and batch programs.
Information Associate
Attend EDS Information Analyst College in Indianapolis, IN.
Graduated in March 1998.
SAS Programmer/Technical Analyst
Assisted the Operations staff as second level support contact
for the Data Center.
Developed REXX programs for automated application startup and
shutdown.
Create and maintain Operations Work Instructions.
Perform analysis of SAS programs Data Center Operations.
Senior Computer Operator/Team Leader
Analyze IBM Mainframe processes that would benefit from
automated operations.
Senior Computer Operator
Supervise and train IBM Mainframe control room operators.
Computer Operator
Monitor IMS & CICS systems.
Computer Operator
Monitor mainframe system availability.
Execute nightly batch cycles.
Computer Operator
Attend EDS Operations Development Program in Troy, MI.
Graduated in January 1986.
Performed reel tape batch processing, punch card preparation,
and laser printer output.
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