HIGHLIGHTS

• More than 10 years SAS and clinical trial experience using statistical analysis and clinical data
• Experience with phase I to Phase IV patient registry, safety and efficacy and Lab data systems
• Significant experience in regulatory setting with knowledge of 21 CFR part 11, ICH, CDISC, SDTM, ADaM, etc
• Experience with SQL and SAS that query, access, analyze and report clinical trial data for various phases
• Strong analytical capabilities, Data warehousing, logic design and modeling with business operation experience
• Advanced knowledge in bio-statistics quantitative analysis with large data system/product life cycle experience
• A good team player, detail and customer oriented interpersonal and communication skills

TECHNICAL SKILLS

• Language: SAS, SPSS, S-PLUS, C/C , MFC, VB, html, Perl, XML
• Database: ORACLE, MS-Access, PL/SQL, ISQL, SQL-PLUS, ODBC
• Package: SAS Base, Macros, STAT, SQL, AF, EIS, Graph, Access, Share, Connect MS-Office, COGNOS
• OS: Unix, Linux, Solaris, Workstation, Mainframe, Windows NT/2000/XP/9x, DOS, Novell, TCP/IP

PROFESSIONAL EXPERIENCE

Statistical Analyst

Confidential

• Perform statistical programming and analysis for clinical trials, prepare SDTM/ADaM datasets for different analysis
• Conduct and QC SAS programs and macros to generate statistical output tables and listing for CSR submission
• Provide input as appropriate into all meetings and activities covering all SAS programming aspects
• Work closely with Bio-statistician, data manager and the clients to analyze the results to ensure accuracy

Senior SAS Programmer

Confidential

• Perform SAS programming and statistical analysis for multiple clinical trials, prepare datasets for different analysis
• Write and QC SAS programs to map data exported from database to SAS datasets according to client specification
• Review CRF and provide input as appropriate into data structures design to ensure adherence to the client request
• Conduct SAS programs and macros to generate safety, coding and monitoring listing, tables, patient profiles
• Provide all SAS programming support to ensure timely and complete locking of databases including importing randomization data, third-party data, PK, PD data, etc. and provide transfer of deliverables to the clients
• Help develop and maintain a central macro library validation and review of other programs
• Maintain efficient and professional with internal and external customers in consultation with Cmed management

SAS Analyst

Confidential

• Provide DM supports and conduct SAS programming for multiple therapeutic areas across centers and visits
• Ensure data quality including patient profiles, demographic data, AE/SAE and Lab data of various phases
• Perform data analysis and validate CRF data errors and inconsistency for accuracy and ensure resolutions
• Assist in EDC, CRF/eCRF design and generate CRF Item 12 Listings and CRFs in Clinical Trial System
• Develop statistical and SAS report macros, create and convert transport datasets for regulatory submissions
• Implement data query listings, summary tables and ad-hoc reports with sorting, merging other techniques
• Design and standardize summary reporting system for individual studies and ISS with SAS SQL
• Discuss and communicate with investigator for issues, process improvement and database freeze
• Review study design and UAT validation plan for test execution, complete documentation and ensure progress

System Analyst

Confidential

• Provide statistical supports for various phases of clinical trial studies and projects
• Develop and improved central data repository and made them quickly accessible to care providers
• Manage large healthcare/clinical data with automation and integration of Lab processes
• Responsible for SAS support with validation of high quality, complete and consistent clinical trial data
• Validate CRF data consistency and accuracy, ensured resolutions on time, and trained customers
• Provide data management supports for multiple trials and tracked and ensured database lock
• Validate patient profile, demographic, treatment, medical history, adverse event, vital signs and Lab data
• Assist in developing listings, tabulations and graphical summaries for queries and reports with SAS macros
• Maintain relationships with external and internal vendors ensured government regulatory compliance
• Review protocols, CRFs, UAT test plans and completed documentations for System Life Cycle

SAS Analyst

Confidential

• Perform statistical modeling with trial time series for market trend study on utilization with multi variables analysis
• Develop SAS/GRAPH procedures on Workstations and PC's to load and perform competitive analysis
• Conduct business trend analysis with multidimensional reports using SAS Macro, ODS PROC GPLOT
• Establish connection between warehouse Unix and application server Windows NT using SAS/CONNECT
• Generate yearly and monthly reports using PROC TABULATE, PROC REPORT over client server environment
• Develop accuracy code for statistical analysis of amplitude spectrum measurement
• Improve database query performance and resource using PROC SQL

System Designer

Confidential

• Designed and developed quantitative data analysis with data warehouse for regional municipal data center
• Developed SAS codes for time series analysis, regression analysis using SAS STAT with PROC ANOVA, REG etc.
• Created SAS data sets from the flat files with SAS/BASE
• Developed Unix shell scripts for batch processing and redesigned query codes with macros for re-use
• Designed data warehouse with ETL from data source through staging
• Generated the output table using SAS Macro, ODS HTML, RTF, PDF for researches
• Developed and designed SAS User Interface for the relational database system using Visual Basic
• Conducted unit and integration tests for SAS queries to Records and False Alarm Database Management System
• Developed and generated test plans, test case execution, debug and conducted requirements and project tracking
• Assisted the RF testing, data acquisition, analysis for RF Gateway verification
• Ensured customer's satisfaction through detailed requirement analysis, planning and progress reviews