SUMMARY

• Over 7+ years of professional experience as a SAS Programmer in the pharmaceutical, clinical research and healthcare industry
• Strong knowledge of the drug development process with strong experience of analysing and reporting in phase I, II, III and IV of clinical trial data
• Extensive experience in SAS products including SAS/BASE, SAS/MACRO, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/SQL, SAS/GRAPH
• Extensive experience in extracting data and creating SAS datasets from various sources like Oracle database, Access database, Excel and flat files using Import techniques
• Excellent working experience in manipulating datasets: Cleansing, Merging, Sub - setting by using SAS data steps and procedures
• Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating & documenting tables, listings and graphs for clinical study reports
• Skilled in creating programs to validate dataset’s compliance to CDISC, SDTM and ADaM standards
• Proficient in developing my own codes as well as modifying existing ones
• Good working knowledge of Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical examination and Vital Signs (VS)
• Created transport files for electronic submission to FDA
• Collaborated with Bio-Statisticians to develop Analysis Data Sets (ADS)
• Generated Analysis Data Sets (ADS) for both Safety and efficacy parameters based on the guidelines provided in the Statistical Analysis Plan(SAP)
• Extensively dealt with SAS Macro facility in coding macros for reusable programs
• Excellent knowledge of SAS Procedures: PROC FREQ, PROC UNIVARIATE, PROC REG, PROC TTEST, PROC ANOVA (Categorical and Continuous data analysis)
• Generated reports using PROC REPORT, DATA NULL and PROC TABULATE for customized report writing
• Experience in producing RTF, PDF, and HTML files using SAS ODS
• Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA
• Accustomed to working in challenging environments under deadlines, excellent analytical and problem solving skills
• Good communication skills and excellent ability to work well in a team

TECHNICAL SKILLS

SAS Products: SAS 9.1.3, BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/REPORT, SAS/SQL, SAS/CONNECT

SAS Procedures: Print, Means, Univariate, Freq, Sort, Summary, Format, Transpose, Compare, Correlation, Regression, SQL, Tabulate, Import, Export, Life Test, GPlot, GLM, Mixed, CPort, Catalog

Languages: HTML, SQL, XML

Databases: Oracle Clinical, MS Access.

Other Utilities: Microsoft Office (Excel, Word, Power point)

OS: Windows XP/ 2000, UNIX, Windows 7

PROFESSIONAL EXPERIENCE

SAS Developer

Confidential, Dallas TX

Responsibilities:

• Clinical data analysis and creation of reports by extensive use of Base SAS, SAS/Macro, SAS/SQL and SAS/Graph.
• Involved in the data analysis of safety and efficacy data.
• Used procedures like IMPORT and EXPORT to obtain and load data from MS Excel and MS Access.
• Generated detailed and self-explanatory reports extensively using PROC REPORT.
• Production of Customary Reports and user friendly interfaces.
• Performed exploratory statistical data analysis using various statistical procedures like PROC FREQ, PROC MEANS, PROC SUMMARY and PROC UNIVARIATE.
• Created datasets and generated reports using PROC TABULATE, PROC REPORT, SAS ARRAYS, PROC SQL and MACROS.
• Formatted HTML, Excel and PDF reports using SAS output delivery system (ODS).
• Worked with statisticians, physicians and performed ad hoc data exploration and standardized reporting.

Environment: SAS 9.4, SAS BASE/MACRO/SQL/ODS/STAT, SAP, Proc SQL

Confidential, Marlborough, MA

Clinical SAS Programmer

Responsibilities:

• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials
• Extensive experience with the SAS programming and in data step and with various SAS Procedures in Base SAS and SAS/Stat, including thorough knowledge of SAS Macro Language
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL, SAS/Connect, SAS/Access
• Data extraction from the Clinical databases and created SAS statistical analysis files for regulatory submission to FDA approval
• Performed program documentation on all programs, files and variables for accurate historical record and for future reference
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time to time
• Conducted statistical modeling for both continuous and categorical data, including linear regression, nonlinear regression, ANOVA, GLM model, repeated measures etc.
• Produced accurate, precise tables and graphs for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part 11, FDA and other regulatory compliance
• Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS)
• Data transmission and integrity check of the existing and in-house Clinical Trial Systems
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones
• Produced quality customized reports by using PROC REPORT and also provided descriptive statistics using Proc Means Proc Univariate and Proc Frequency
• Developed and maintained programs in SAS using SAS tools for Windows and UNIX in a user support environment
• Retrieved ORACLE tables from Oracle Clinical with Proc SQL using ‘Pass through Facility’
• Formatted HTML and RTF reports, using SAS - output delivery system ODS
• Used the SAS Macro facility to produce weekly and monthly reports

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/CONNECT, Excel, Access, Oracle Clinical, SQL, UNIX and Windows XP

Confidential

Business Analyst

Responsibilities:

• Extensively worked with Health care data which includes various claims, membership details and of the members
• Imported Data from relational database into SAS files per detailed specifications
• Worked on developing the SAS codes in generating the patient-level analysis files from Insurance claims data like Outpatient claims, Inpatient claims and Pharmacy claims with help of diagnosis, procedure and drug codes
• Involved with key departments to analyse areas and discuss the primary model requirements for the project
• Involved in analysis, development, implementation, and provided technical support to business needs using SAS in Window environment
• Performed daily weekly and monthly campaigns as per the deliverable schedules
• Maintained and analysed inpatient hospital admission data
• Created reports using Proc Report, Proc Tabulate and ODS statements to generate output formats in HTML PDF and RTF
• Used stored procedures to execute data process and refreshes for the Claims group
• Created reusable Macros and used existing macros for Data Cleansing, Validation analysis and Report generation
• Reduced I/O by controlling the space required to store SAS data sets using compression techniques, length statements, or eliminating variables and observations
• Designed new datasets with the modified values in tables using SAS statements, procedure and SAS functions
• Reduced programming time by developing reusable SAS programs which in corporate data step views, DATA steps that write SAS programs
• Also used SAS Statistical procedures like PROC REPORT, PROC TABULATE, PROC FREQ, PROC MEANS and Data steps, LIBNAME and SQL pass-through facility to accomplish the tasks
• Used SAS EG (Enterprise Guide) query builder to run queries against the tables and sub-setting the data

Environment: SAS EG, SAS/BASE, SAS/MACRO, SAS/ODS, ORACLE, SQL Server

Confidential

Statistical Analyst

Responsibilities:

• Clinical data analysis and creation of reports by extensive use of Base SAS, SAS/Macro, SAS/SQL and SAS/Graph.
• Involved in the data analysis of safety and efficacy data
• Used procedures like IMPORT and EXPORT to obtain and load data from MS Excel and MS Access.
• Generated detailed and self-explanatory reports extensively using PROC REPORT
• Production of Customary Reports and user friendly interfaces
• Performed exploratory statistical data analysis using various statistical procedures like PROC FREQ, PROC MEANS, PROC SUMMARY and PROC UNIVARIATE
• Created datasets and generated reports using PROC TABULATE, PROC REPORT, SAS ARRAYS, PROC SQL and MACROS
• Formatted HTML, Excel and PDF reports using SAS output delivery system (ODS)
• Worked with statisticians, physicians and performed ad hoc data exploration and standardized reporting

Environment: SAS 9.4, SAS BASE/MACRO/SQL/ODS/STAT, DATA NULL, Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Freq, Proc Tabulate, Proc Report

Confidential

SAS Programmer

Responsibilities:

• Involved in SAS programming for Clinical trials e-submission to CRF
• Reviewed protocol and Case Report Forms to identify errors of the clinical trial data
• Developed specifications for SDTM conversion and mapping programs
• Validating all the tables and listings using validation rules in programming SOP’s
• Design and develop standards of SAS macro’s for SDTM domains
• Developed specifications for ADaM conversion and mapping programs
• Design and develop standards for SAS macro’s of ADaM domains
• Developed SAS macros to create tables, listings and graphs (TLG) for routine reports
• Validated SAS programs and output results by writing independent code

Environment: SAS 9.3, SAS/base, SAS/macro, SQL, MS Office, Excel, Windows