SUMMARY

A SAS professional with over twelve years of experience in SAS clinical systems programming, development and data processing within a team environment including mentoring Junior Programmers and data mapping. Two years design, analysis and SAS programming of a database for approximately twenty anti-psychotic Aventis compound protocols. Programming and analysis for Phase I-IV Infectious Diseases leading to the successful submission of HBV Baracludein 2004. Phase IV Programming support for HIV Reyataz and Sustiva.DBA/DB2 large mainframe database for two years.

HARDWARE/SOFTWARE

SAS 9.2 PC, EXCEL SAS 8.2 UNIX, SAS macros, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/JMP, SCL, PROC SQL, WIN NT, OS, MVS, JCL Utilities, UNIX, ISPF, SQL, Maple, IBM DB2, COBOL, Oracle7, S-plus, Windows 7

EXPERIENCE

Confidential

SAS Programmer

• Data Mapping and Integration. Reviewed SDTM standards,
• Mentored junior programmers, lead team of four in data mapping.
• Wrote SAS macros and analysis. Prepared many Excel reports
• Participated in many meetings as data consultant.
• Performed many SQL queries on large databases and used Informatica and other tools.
• Data reconciliation/analysis of legacy studies with extensive down loads from many sources.

Confidential

Contractor/SAS Programmer

• Maintenance of Phase III cardio vascular programs database programs, home based.
• Short term contract while a full time programmer was sought to be based in England.

Confidential

Principal Analyst

• Programmed and analyzed many statistical tables for Phase I-IV HCV and HIV protocols to meet several regulatory agency requirements. These tables included safety, vitals, ECG, concomitant medications, virology, proof-of-concept, pharmacokinetics, and pharmacodynamics.
• Designed stat reports and graphs, Utilized PROC SQL, PROC UNIVARIATE, STAT procs and macros. SAS 8.2 and PC NT.
• Successful 2004 Baraclude NDA submission team of five.
• Routinely used of SQL queries on large databases.
• Programmed and analyzed tables, listings, and graphs for Gatiflaxocin, Reyataz, Sustiva, and Baraclude to meet Discovery Medicine Clinical user needs.
• Extensive interactions with medical doctors, study directors, pharmacokineticists, statisticians, and clinical scientists leading to custom designs in a clinical discovery team environment in person and in documentation.
• Extensive work with data managers in data evaluations, specifications, and CRF design,
• Many awards received for high quality, productivity, and timely delivery.
• Extensive S-plus and SAS Graphics development for submission graphics.

DiverseSAS Programming Consulting

Confidential

• Programmed and analyzed many ISS statistical tables over 40 pain management compound Phase II/III protocols. These tables included safety, vitals, ECG, conmed and tables.
• Stat reports included survival reports using ProcLifetest and plots. NDA submission team of five. Utilized PROC SQL, PROC UNIVARIATE, STAT procs and macros. SAS 8.2 and NT.
• 6 month assignment.

Confidential

• Programmed many statistical pharmacokinetic, ecg and vital sign reports for Phase I cardiovascular compound protocols using PROC MIXED, PROC MEANS and PROC REPORT to meet specific international government and regulatory requirements.
• Modeled blood pressure and ECG data. Mentored SAS programmers. Statistician-led team of three.
• SAS 8.2, UNIX and Emacs environment.
• 7 month assignment.

Confidential

• Analyzed pharmaceutical diabetes protocols and programmed over 50 SAS patient/data exclusion criteria modules for an Insulin submission to Japan.
• Interacted with the Japanese via email, IBM MVS and ISPF environment.
• Made several SAS PROC SQL programming and analysis presentations to communicate specifications and to train statisticians in the use of the product.
• 7 month assignment.

Confidential

• Programmed reports for 6 pediatric patent extension dermatology protocols for Schering-Plough Corp.
• Worked with a team of 4 preparing over 30 clinical trial reports through the extensive use of SAS Macro language.
• Integral part of the HMR team that was transitional to continue working on the data analysis of the anti-schizophrenic compound M100907 .
• FSEDIT and UNIX environment.
• 7 month assignment.

Confidential

• Programmed and analyzed data for over 20 anti-schizophrenic compounds M100907 pivotal Phase I, II and III clinical trial studies. Extensive data base analysis.
• Programs designed and wrote in adherence to HMR FDA programming standards.
• Documented and interfaced with international management and scientific personnel.
• Functioned as part of a three-person international team.
• Statistical Procs, SQL and PROC FORMATS were used.
• 18 month assignment.

Confidential

• Designed, debugged and tested marketing SAS, COBOL II and DB2 programs on IBM/MVS system.
• Maintained, debugged and tested marketed 20 SAS programs.
• Developed a Database Marketing, Redemption, and Sales Reports System in SAS.
• 6 month assignment

Confidential

• Worked on the Sprint Global One Aged Receivables Report System.
• Coded, tested, designed, debugged and implemented over 20 SAS Programs on IBM/MVS.
• Wrote technical user documentation.
• Interfaced with Accountants extensively to obtain business requirements and specifications.
• 1 year assignment.