SUMMARY

• Certified Base SAS programmer with over 7 years of experience as a clinical SAS programmer in various pharmaceutical and CRO industries.
• Excellent experience in various phases of clinical trials and strong understanding of study design Protocol, Case report form (CRF), Statistical analysis plan (SAP) and data dictionaries (MedDRA, WHO - DRUG).
• Excellent knowledge and experience in complete GCP and ICH guidelines, SOP’s and 21 CFR Part 11.
• Skilled in implementing SAS on UNIX and WINDOWS environment.
• Extensive experience in using various SAS tools like SAS/BASE, SAS/MACRO, SAS/SQL, SAS/STAT, SAS/ODS, SAS/GRAPH.
• Worked on different PROC’s like, PROC PRINT, PROC FREQ, PROC DATASETS, PROC CONTENTS, PROC MEANS, PROC UNIVARIATE, PROC TRANSPOSE, PROC SUMMARY, PROC COMPARE, PROC FORMAT, PROC SQL, PROC REPORT, PROC SGPLOT,PROC TTEST, PROC BOXPLOT.
• Experience in Proc SQL joins and Proc SQL set operators to combine tables horizontally and vertically.
• Experience in modifying existing SAS programs and creating new SAS Programs using SAS Macros to improve ease and speed of modifications as well as consistency of results.
• Very good Knowledge of CDISC-SDTM, ADaM standards for regulatory submissions, FDA and ICH guidelines.
• Experienced in creating and validating SDTM, ADAM datasets as per CDISC standard.
• Good working knowledge of Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE), Laboratory data and Efficacy related data following CDISC standards.
• Excellent work experience in generating and validating reports, Tables, Listings and Graphs according to Statistical Analysis Plan and company standards.
• Expert in using SAS/ODS to create HTML, RTF and PDF output files and Data Null to generate ad-hoc and customized reports.
• Excellent organizational, teamwork, presentation, problem solving, decision making and interpersonal skills.

TECHNICAL SKILLS

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

Office Tools: MS office .

Operating Systems: Windows 98/2000/XP/Win-7/Win-8, UNIX.

Languages: SAS v 8/9/9.1.3, SQL, C.

Databases: Oracle, MS-Access

PROFESSIONAL EXPERIENCE

Confidential, Gaithersburg, MD

Clinical SAS Programmer

Responsibilities:

• Participated in reviewing developed SAS code to eliminate any possible errors and improve functionality for many studies and in reporting those issues to the data management team.
• Participated in reviewing protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical trials.
• Created an annotated CRF document that maps CRF data sets to SAS data sets.
• Produced SDTM datasets from the existing SAS datasets as per the SDTM specifications.
• Developed Analysis datasets for Safety and Efficacy data (Demographics, LAB, Adverse Events, Medical History, Physical Examination, Concomitant Medications, Vital signs, etc.) as per SAP.
• Generated statistical analysis tables, listings, and figures to analyze clinical trial data.
• Extensive interaction with the statisticians to understand the requirements on statistical methods and models.
• Performed Production and Validation of datasets, tables, listing and graphs using SAS Tools - SAS/Base, SAS/Macros, SAS/Graph and SAS/SQL.
• Generated high quality reports in HTML, RTF and PDF formats using SAS ODS.

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, UNIX, SAS/Enterprise Guide.

Confidential, Lawrence, MA

Clinical SAS Programmer

Responsibilities:

• Generated Tables, Listings and Graphs using SAS Tools - SAS/Base, SAS/Macros, SAS/Graph and SAS/SQL.
• Created CDISC SDTM and ADAM compliant datasets by following the standard Meta data and controlled terminology.
• Created an annotated CRF document that maps CRF datasets to SAS datasets.
• Worked with all kinds of Clinical Trials data such as Demographic data, Adverse Events (AE), Laboratory data (Lab data), and Vital Signs.
• Produced SDTM data sets from the existing SAS data sets as per the SDTM 3.1 specifications.
• Produced analysis data sets for various domains according to the ADAM standards.
• Created and Validated Analysis datasets, Tables, Listings and Ad-hoc reports.
• Used Output Delivery System (ODS) facility to write safety and efficacy reports directing SAS output to RTF and PDF.

Environment: SAS/BASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/SQL, WINDOWS.

Confidential, San Antonio, TX

SAS Programmer/ Analyst

Responsibilities:

• Performed data cleaning by analyzing and eliminating duplicate and inaccurate data using PROC FREQ, PROC UNIVARIATE, and macros in SAS.
• Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical trials.
• Designed and implemented statistical reporting process for clinical data analysis.
• Defined various user defined formats using PROC FORMAT besides using different kinds of predefined INFORMATS and FORMAT statements.
• Used SAS MACROS in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Developed SAS programs to create TLG’s by using procedures like PROC REPORT, PROC TABULATE, PROC GPLOT, PROC FREQ and PROC UNIVARIATE.
• Performed Validation of datasets, tables, listing and graphs.
• Used DATA NULL technique for producing highly formatted and highly customized reports.
• Generated ADHOC reports using the SAS procedures, ODS pass through facility and PROC TEMPLATE to generate output in different formats like HTML, PDF and RTF

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/STATMS EXCEL.

Confidential

Clinical SAS Analyst

Responsibilities:

• Setting up SAS datasets by extracting data from Excel tables into SAS datasets using PROC IMPORT and Data steps.
• Wrote and modified SAS code in windows environment.
• Responsible for creating, testing and maintaining SAS programs for clinical studies according to company standard procedures.
• Used SAS /Base to perform sorting, merging and updating and generated reports.
• Created Tables and Listings and Common Clinical Trial Graphs using SAS Tools - SAS/Base, SAS/Macros, SAS/Graph and SAS/SQL.
• Performed Validation and QC of tables, listing and graphs.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using Proc Means, Freq, and Univariate.
• Formatted HTML, PDF and RTF reports, using SAS - output delivery system ODS.

Environment: WINDOWS, SAS/BASE,SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS.