SUMMARY

• 6 years of extensive experience in SAS programming, database design, data analysis, development and implementation.
• Substantial working experience in Clinical Research, Pharmaceutical, Healthcare and Biotechnology industry.
• Strong experience in Windows/Unix/Linux - based SAS 9.1.3/9.2, including SAS/BASE, SAS/MACRO, SAS/SQL, SAS/ODS, and SAS/GRAPH.
• Professional experience in SAS/SQL, SAS/INFILE, and SAS/IMPORT for converting and importing various formats of external data files into SAS datasets and creating libraries.
• Excellent experience in data manipulation and dataset preparation: cleansing, merging, combining, splitting, and validating by using SAS statements FORMAT/INFORMAT, MERGE, SUBSET and procedures PROC SORT, PROC TRANPOSE, PROC APPEND and PROC RANK.
• Strong programming skills in developing and debugging SAS MACRO to access, extract, modify, merge and analyze clinical data and output statistical analysis into files, tables, listings and graphs
• Superior experience with SAS/ODS and SAS/EXPORT for exporting SAS results into different file formats including RTF, HTML, PDF, PS, XML, etc.
• Proficient in producing the customized tables in reports for clinical trials by applying PROC REPORT, PROC TABULATE, and DATA NULL .
• Expertise in producing the customized graphs by employing SAS/GRAPH procedures PROC GPLOT.
• Proficient use of statistical procedures in SAS to perform statistical analysis, including PROC GLM, PROC ANOVA, PROC MIXED, PROC TTEST, PROC GENMOD
• Advanced experience in many areas of statistics, including linear single and multiple-variable regressions, logistic regression categorical data analysis, multivariate analysis, nonparametric methods, experimental designs, etc.
• Familiarized in the process of clinical trials of Phase I through IV and FDA procedures of FDA 21 CFR part 11 and regulations for IND and NDA submission.
• Experience in maintaining CDISC STDM models and knowledge of Case Report Tabulation Data definition Specification Model.
• Experience with ISS and ISE for NDA submission to FDA

TECHNICAL SKILLS

SAS Products: Unix/Linux/Windows Based SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS/ODS, SAS/GRAPH, SAS/ANALYST, and SAS Enterprise Miner.

Programming Languages: C/C++, HTML,SPSS,OPENCDISC

Database: MS Access, MS SQL Server 2005/2008 Oracle Server 9i/10g/11g and MySQL

MS Office: Word, Excel, PowerPoint, Outlook

PROFESSIONAL EXPERIENCE

Senior SAS Consultant

Confidential, Rockaway,NJ

Responsibilities:

• Create Submission Datasets in CDISC SDTM,ADaM standards according to SDTM Implementation Guide 3.1.3,3.2 and ADaM Implementation Guide 1.0
• Generate safety and efficacy tables from ADaM and listings from ADSL and SDTM datasets.
• Compile individual study SDTM/ADaM datasets into ISS/ISE ADaM Datasets.
• Generate ISS/ISE tables and listings for FDA Submission
• Create Define.xml for individual studies and ISS & ISE SDTM and ADaM
• Run SDTM and ADaM Datasets XPT files in OpenCDISC and ensure the correctness of datasets for submission purpose.
• Use SAS MACRO to code a series of programs that accomplish similar tasks as well as create procedures that generate results as requested.
• Build or apply existing macros to produce customized graphs, applying DATA step and several statistical procedures like PROC GPLOT were used to build graphs for inclusion of reports.
• Team up with other SAS programmers in a group, along with principal investigators, statisticians and data managers on several clinical trials including scar treatments, diabetes trial, influenza vaccine trial, etc.
• Program in SAS independently: coding, documenting and testing required programs.
• Pair up with programmer in the group, compared outputs and proofread programming codes, ensure the accuracy of program results, program and results validation.
• Prepare detailed analysis plan from study protocol with statisticians.
• Ensure datasets and programming codes meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Organize datasets into forms for statistical analysis by merging, combining, splitting, and coding, and performed edit-check for datasets to assure the quality of the datasets.
• Perform quality assurance procedures of other programmers work, validation of SAS programs, and debug complex programming code by using DATA step.
• Direct customized SAS outputs to RTF or HTML files by Output Delivery System (ODS) facility.
• Conduct regression, correlation studies and analysis of variance by using PROC CORR, PROC GLM, and PROC ANOVA.

Senior SAS Programmer

Confidential, Rockville, MD

Responsibilities:

• Worked with clinical research staff to provide SAS programming support to clinical study group for clinical trial projects on patients with cardiovascular disease.
• Prepared detailed analysis plan from study protocol. Prepared, documented and tested required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports.
• Developed, modified, validated and implemented SAS programming work according to SAP.
• Validated programming output with other programmers output and mockups in SAP using PROC COMPARE.
• Used DATA step to derive analysis dataset from raw dataset using define feature in SAP and Clinical Report Forms.
• Designed and created SAS datasets from various sources like Excel spreadsheets, flat files, statistical analysis files, tables, listings, and graphs for all phases of clinical drug trials studies.
• Used various procedures like PROC REPORT, PROC FREQ, PROC TABULATE, PROC MEANS and PROC SUMMARY to generate tables, patient data listings and reports according to SAP.
• Contributed to ISS analysis datasets and reports TLF for clinical studies.
• Created tables, graphs, and listings for inclusion in clinical study reports and regulatory submissions, as well as maintained existing ones by using SAS MACRO.
• Wrote customized safety and efficacy reports directing SAS output to RTF and HTML files using ODS facility.
• Conducted and generated the regression, correlation studies and analysis of variance by using PROC REG, PROC CORR, PROC GLM, and PROC ANOVA.
• Converted existing raw data into CDISC SDTM domain datasets release 3.1 standards using mapping techniques and reviewed CRFs (Case Report Forms) to ensure the data consistency and adequacy with the protocol requirements
• Load and validate CDISC SDTM- format clinical trial data files for submitting data to the regulatory authorities.

Senior SAS Developer

Confidential, Gaithersburg, MD

Responsibilities:

• Creating a list of macros from scratch that does:
• Driver (autoexc -assigning data set directory path, specifying for each study data set on the server)
• Hy’s law macro ( - A standard macro program which can be utilized in any phase of drug studies. it finds patient(s) with Hy’s law condition according to the definition of Hy’s law following the FDA standard, and output the subject ID for patient(s) with Hy’s law conditions).
• Learning the industry standard macro code and manuals that other programmers created and invoke a group of standard macro programs including standard demographic, adverse event, concomitant medications, dosing, vital science, medical history macros. hy’s law plot macro - TBL v.s. AST/ TBL v.s ALT( utilizing the annotate facility in the PROC GPLOT to plot out all patients’ lab results as well as label patients with Hy’s law condition.
• Working closely with Statisticians and Medical Doctors on how tables/listings/graphs are formed and organized to present information
• Creating macro that generates listings and graphs that, such as patients profiles and patients with abnormality post-drug.
• Program testing and debugging.
• Compositing Programming Specification along with the programmer lead, Statisticians and medical writers.

SAS Programmer/Statistical Analyst

Confidential, Edison NJ

Responsibilities:

• Created SAS datasets using SAS/CONNECT, SAS/ACCESS to access remote clients Cleaned datasets and loaded clinical data into databases for further reporting based on report specification
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access
• Met with SAS Developer/BioStatistician/Clinical Data Coordinator/Clinical Data Manager/Clinical Research Coordinator for clinical trial protocol reviewing, Clinical Data Management Plan reviewing, and Clinical Study Report submitting
• Wrote SAS code for data management and reporting, and performed validation, including testing SAS code
• Techniques used in SAS include file merging, frequency and Report, Transpose, Summary, and Means Procedures, writing to external files
• Developed routine SAS macros to create tables, graphs and listings
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE
• Created graphs in MS - Excel by transporting SAS data sets into Excel spreadsheets
• Formatted HTML and RTF reports, using SAS - output delivery system ODS
• Used the SAS Macro facility to produce weekly and monthly reports
• Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation, including testing SAS code
• Provided sample size estimation and power estimation
• Wrote code using SAS/Base and SAS/Macros to extract clean and validate data from Excel file, Access Database, and Microsoft SQL server
• Data transmission and integrity check of the SAS datasets