SUMMARY

• SAS Base Programmer with about 7 years of experience in Statistical Analysis, Reporting and Clinical Data Management in Pharmaceuticals and Clinical Research Organizations.
• Experience in handling complex transformations using SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS and SAS Enterprise Guide.
• Good command in using PROC IMPORT and PROC EXPORT, SAS/ACCESS, SAS/SQL to import different types of external data files (csv, xls, txt, etc) into SAS library and export SAS datasets into different types of external data files.
• Performing data transformations using DATA STEP statements for grouping data and combining SAS datasets in various ways by applying functions, transposing, arrays, appending datasets and also generating reports using PROCEDURES like Summary or Report Procedures and using PROC SQL.
• Good command in producing tables, listings and graphs with reporting using SAS procedures such as PROC PRINT, PROC REPORT, PROC TABULATE, PROC MEAN, PROC GPLOT, PROC TEMPLATE and PROC GCHART.
• Producing data in various output formats including in specific output formats like TXT, RTF, PDF, and HTML etc. using SAS ODS (output Delivery System).
• Good comprehension of CDISC (SDTM and ADaM) guidelines, Good Clinical Practices (GCP), Good Clinical Data Management Practice (GCDMP), International Conference of Harmonization (ICH) MedDRA Coding, FDA guidelines in 21 CFR Part 11 for electronic submissions and other regulatory guidelines.
• Good understanding of Clinical Trial protocol and CRF’s annotation and participated in review of protocols, CRF’s, test databases and Statistical Analysis Plan (SAP).
• Experience with Clinical Study Methodologies and Clinical Trials Data like Demographic Data, Adverse Events, Serious Adverse Events, PK/PD, Vitals, Laboratory Data under Clinical trials phase I - phase IV in different therapeutic areas like Oncology, Cardiology, Autoimmune diseases etc.
• Experience in programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Exceptionally well organized and ability to quickly adapt to new applications and platforms.
• Strong work ethics, analytical and communication skills and willingness to work hard.

TECHNICAL SKILLS

SAS Skills: SAS/BASE, SAS/MACROS, SAS/ODS, SAS/ACCESS, SAS/SQL SAS/GRAPH, SAS/STAT, SAS Enterprise Guide

Clinical/Safety Databases: ORACLE Clinical, AERS, ARGUS, PMED

S SAS PROCEDURES: Proc Frequency, Proc Means, Proc Univariate, Proc Copy, proc DatasetsProc Anova, Proc Corr, Proc Reg, Proc GLM, Proc Summary,Proc ContentsProc Compare, Proc Setinit, Proc Chart, Proc Gchart, Proc Plot, Proc GplotProc Options, Proc Print, Proc Sort, Proc Printto, Proc Import, Proc ExportProc Format, Proc Rank, Proc Transpose, Proc Compare, Proc AppendProc Cport, Proc Cimport, Proc Copy, Proc Tabulate, Proc ReportProc Catalogs, Proc Access, Proc Ttest

Operating Systems: Windows XP/ NT/ 98/ 2000, UNIX

Other tools: MS-Office, MS-Visio, MATLAB, MATHCAD, FTP Tool

PROFESSIONAL EXPERIENCE

Confidential, RTP, NC

Sr. SAS Programmer/Analyst

Responsibilities:

• Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation, including testing SAS code.
• Prepared clinical data listings and summaries for statistical analysis and analyzed clinical data using SAS system.
• Developed reports using PROC REPORTS, PROC TABULATE and DATA NULL .
• Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
• Provided programming expertise in the generation of data listings, summary tables and graphs for interim and final analysis.
• Produced data models like Study Data Tabulation Model (SDTM), Analysis Dataset Model (ADaM) as per CDISC Standards.
• 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.
• Interacted with statisticians to program efficacy tables.
• Created graphs by using the SAS annotate facility and SAS/GRAPH procedures.
• Produced customized reports by using PROC TABULATE, REPORT, SUMMARY and also provided descriptive statistics using PROC MEANS, FREQ, and UNIVARIATE.
• Maintained and wrote reusable SAS MACROS.
• Generated numerous ad-hoc reports on routine basis.
• Used SAS procedures for pre-processing data, SQL queries, data analysis, generating reports, graphs and statistical analyses.
• Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Accessed various database to gather data, performed a table lookup and translated data values for meaning and readability.
• Downloaded data from Oracle using SQL within SAS to be analyzed and exported to Excel for further analysis.
• Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.

Environment: SAS v9.2, SAS/SQL, SAS/BASE, SAS/MACROS, SAS/GRAPH, Oracle Clinical, AERS and Windows XP

Confidential, Billerica, MA

Clinical SAS Programmer

Responsibilities:

• Involved in writing the specifications for Analysis datasets (Demographics, Vitals, AE, and Labs etc).
• Modified specifications for various analysis datasets as per client specification.
• Mapped the eCRF to generate the specifications for the Clinical trial studies for Phase II clinical trials.
• Derived various algorithms and mathematical equations to generate the derived variables.
• Worked on generating the ADS for PK analysis for Phase II A clinical trials.
• Followed World Wide SOPs that are used to maintain coding ethics.
• Developed new programs as per the client requirements using SAS Base, SAS Macros and SAS/SQL procedures.
• Worked as a Quality Control Programmer to make sure that the generated ADS, TLFs are as per the SAP and Protocol.
• Worked on different therapeutic areas like Oncology, Cardiology, Autoimmune diseases for Phase II and Phase III clinical trials.
• Worked on documentation of all the study material required for audit.
• Generated TLF’s and statistical significance values using various statistical procedures like PROC GLM, PROC PHREG etc.,
• Worked on adhoc programming for changes in ADS, TLFs as per the client modifications.
• Reviewed the client comments and passed on the data related and Confidential comments to the client.
• Performed log check to ensure that log is clean.
• Worked on various non parametric statistics used in Oncology studies to perform statistical analysis.
• Used Proc report for generating tables and listings.
• Performed Visual Validation for TLF’s.

Environment: SAS v9.1, SAS/BASE, SAS/ODS, SAS/ACCESS, SAS GRAPH, SAS/STAT, ARGUS, UNIX

Confidential, Cambridge, MA

Clinical SAS Programmer/Analyst

Responsibilities:

• Developed SAS programs for creating intermediate data sets, generated statistical reports and graphs as per statistical analysis plan.
• Generated tables and listings based on CDISC (SDTM and ADaM) standard.
• Processed adverse event (AE) analysis datasets for FDA submission.
• Created Integrated Summaries of Efficacy (ISE) and Safety (ISS) as per FDA compliance.
• Modified/created various macro definitions for preparation of analysis plans.
• Performed Data analysis, generated reports, tables, listings, figures and graphs using SAS Tools - SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL, SAS/Connect and SAS/Access.
• Worked on edit check programs to maintain data consistency and data validation.
• Conducted SAS multivariable statistical analysis of clinical trial projects and generated reports.
• Imported data from Oracle into SAS datasets.
• Produced ad-hoc reports upon request from other teams.
• Performed inner and outer joins across tables using PROC SQL.
• Created programs for comparison of data structures, formats and variables across the project using Compare Procedure.
• Reports were generated in PDF, RTF and HTML formats using SAS ODS.
• Converted existing raw data into CDISC standards and reviewed CRFs to ensure consistency and adequacy in data in order to meet the objectives defined in protocol.
• Provided technical support to the clinical study teams.
• Validated programs developed by fellow programmers.
• Coordinated with other departments to achieve regulatory project goals.
• Worked in collaboration with statisticians and data management to generate and to resolve queries.

Environment: SAS 9.1.3, SAS/BASE, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, ORACLE 10g, Windows.

Confidential

SAS Programmer I

Responsibilities:

• Managed missing data and used sort and merge techniques to get the required output.
• Developed SAS programs to generate data summaries, data listings and safety analyses (SAE reconciliation).
• Used SAS Data steps, SAS Proc steps, SAS Macros and SAS SQL for development.
• Performed data analysis using SAS/STATS procedures FREQ, UNIVARIATE, TTEST and NPAR1WAY.
• Used PROC REPORT to prepare reports that combine both summary and detailed data.
• Prepared and tested required programs for inclusion in integrated clinical, statistical summary reports.
• Graphical displayed analyzed data by using PROC PLOT, PROC CHART etc.
• Performed Data Quality Checks using various SAS Base Procedures.
• Involved in Data cleaning and validation using PROC COMPARE.
• Used SAS ODS to generate reports on safety and baseline characteristics in RTF,PDF and Excel
• Investigated and fixed several issues and proactively suggested new output formats.
• Coordinated with the team for various enhancements in the process.
• Assisted in pre-release testing and implementation of all new SAS release and products.
• Managed the assembly, review and technical approval for regulatory dossier and documents for assigned projects
• Developed SAS programs to validate converted datasets, also validated programs developed by co-programmers.
• Generating tables and listings based on CDISC (SDTM and ADaM) standard.
• Created summary reports and tabular reports.
• Created standard & adhoc reports.
• Involved in pre-processing of adverse event analysis datasets for FDA submission.

Environment: SAS v8.2, SAS/BASE, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, MS Excel, AERS, Windows