CAREER SUMMARY

Twenty-five years experience in structural programming, systems analysis,

and data analysis in a wide variety of industries, including biotech,

medical devices, finance, and aerospace. Expert in developing and

implementing IT projects, including designing, coding, testing,

debugging, documenting, installing, and maintaining diverse and evolving

applications; Strong experience in software auditing, validation and

quality assurance; Highly experienced in meeting rigorous FDA standards.

Provides effective project leadership and governance of teams greater

than ten members.

EXPERIENCE

Independent Consultant Nov

2002 - Mar 2009.

Senior Clinical SAS Developer/Analyst. Managed contracts for external

clients (i.e. MedTrials, Genzyme, Imclone); Developed SAS reports for

statistical analysis and FDA submission preparation. Output was

generated to Excel for Clinician's ease of use; Extracted and transformed

information from database for brochure production and various conference

presentations. Analyzed specifications and converted data to current

registry standards, which improved data registry quality. Within FDA

standards, performed traditional clinical trials analysis with listings,

figures, and tables.

. Developed macro programs, reducing report preparation time by 20%.

Project Manger/Software and Systems Developer. Developed methods,

policies, and procedures for software development at a startup company;

functioned as project manager and software/systems developer, creating

databases and developing client relationships. Prepared project plans and

cost estimates.

. Developed software procedures that led to repeat clients.

Senior Statistical Project Manager/ Developer. Developed and governed

standards and procedures for a new statistics department; Trained new

employees in structural programming techniques; successfully led team in

generating code to produce statistical output; simultaneously

collaborated with four groups, each consisting of statistician, data

manager, clinicians and medical executives. Developed macros for team use

to insure quality information and rapid response for report requests.

. All projects completed on time and within budget.

Senior Statistical Developer. Developed programs to produce statistical

analysis for testing of medical devices at GenProbe; including extracting

and converting data from various sources into the Data Mart.

Senior QA and Validation Software Developer. Responsible for software

auditing and validation and quality control of all department projects at

Pfizer. This included oversight of ten programmer/analyst programs and

reports. Accepted responsibility for accuracy of data included in

submission to regulatory agencies.

. Rapidly acquired project knowledge to properly audit and validate quality

for FDA submissions.

StatProbe, Inc., San Diego, CA

Jan 2001 - Nov 2002.

Senior Operations Manager. Successfully led multiple teams in developing

programs for Amgen, Inc. Designed and populated Data Mart, encompassing

all clinical trial data required to prove product safety; Developed

standard complex SAS macros for consistent company-wide data analysis.

Developed macros to perform thousands of conversions from conventional to

standard units.

Isis Pharmaceuticals, Inc., Carlsbad, CA

Mar 1999 - Dec 2000.

Lead Developer/Project Manager. Recruited, interviewed, hired, trained,

and evaluated a staff of 11 Developers to produce accurate reports for

NDA submission to the FDA. Produced Integrated Safety and Efficacy

Summaries for submissions plus annual regulatory reports of Adverse Event

data; Presented analysis results to Regulatory Affairs Department.

Oversaw database development, statistical analysis reporting, and report

preparation and presentation; Oncology, Psoriasis and Chrons Disease

indications.

. All Projects completed on time and within budget a significant number

under a compressed timeline.

CCN, San Diego, CA Sep

1997 - Mar 1999.

Senior Developer/Analyst in the Information Systems Department. Developed

new SAS on-line health claims applications and maintained older SAS

systems for the user community using SAS /AF, SAS /FSP, SAS /Basics, SQL

on VAX/VMS Alpha, and utilizing DCL for production runs; Extracted data

from Oracle to SAS .

Synteract, Inc, Encinitas, CA Jan. 1997 -

Aug. 1997

Senior SAS Developer. Developed listings and tables for the purpose of

analyzing clinical trial data for various clients.

Parexel International, San Diego, CA

Aug. 1995 - Dec. 1996

Senior Operations Developer. Developed listings and tables for various

therapeutic areas Key team member in developing Standard Operating

Procedures (SOP) for the San Diego site office.

Alliance Pharmaceutical Corp., San Diego, CA

May 1991 - Aug. 1995

Senior Developer/Analyst. Designed and implemented a clinical trials

double data entry system. Developed listings, tables and graphs for

analysis of clinical trials data; Blood Substitute and Cancer

indications.

EARLY CAREER DEVELOPMENT

Systems Development and Analysis. Maintained diverse systems and

developed ad hoc programs and on-line systems for the user community

using the following languages; SAS /Basics, SQL, COBOL, Fortran, and

Assembler. Design and implemented on line Cost of Sales System for the

Finance Group. Developed programs for Retirement and Savings Plans.

HARDWARE, OPERATING SYSTEMS, and SOFTWARE

. IBM 3800 - JCL, FTP, TSO, MVS, UNIX Operating systems, Solaris,

VAX/VMS Alpha - DCL, Window 95, 98, NT, XP Professional, Windows for

Work Groups v6.11

. SAS /Basics, SAS /Graph, SAS /AF, SAS /FSP, SAS /Frame, SAS STAT

(v5.18 - v8.2, v9.1), SQL, COBOL, Fortran, Assembler

. MS Office including Word, Excel, Access, PowerPoint, Visio

PURSUIT OF KNOWLEGDE

Purdue University: Computer Technology

UCSD Extension: COBOL (completed 1985, grade A), Life Sciences

Information Technology Certificate

Professional Training:

Getting the Most from SAS Formats, Statistical Data Mining, SQL

Programming by Example, SAS Macro Language, Customized Reports with SAS

Output Delivery System, Diagnostic and Laboratory Test Analysis, Extended

Compute Blocks in PROC REPORT, Quick Results with the Output Delivery

System, Developing Object-Orientated Applications, Getting Started with

the Frame Entry, Screen Control Language, Graphing with the SAS language,

Common Statistical Methods for Clinical Research, Modernize Your Business

Reports using ODS, Creating Case Report Tabulations for Electronic

Submission to FDA, Web Publishing, Bringing Rhyme and Reason to Your

Data, Using IntrNet to Teach PROC GCHART, Dynamic Drillable Map,

Production Reporting Environment

Professional Associations: SUGI, PharmaSUG (Executive Committee member),

SANDS (Executive Committee Treasurer), DIA

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