SUMMARY

• Sr. SAS Programmer With 6.3 years of experience in working with SAS and SAS tools emphasizing on analysis, developing, design, testing and implementation of various projects for Pharmaceutical and CRO Industries.
• Experience working with Base SAS, SAS/ACCESS, SAS/GRAPH, SAS MACROS, SAS SQL, and SAS ODS in Windows and UNIX environments.
• Exposure to Phase I, Phase II and Phase III clinical trials.
• Commendable knowledge of Study Data Tabulation Model (SDTM), Analysis Dataset Model (ADaM).
• Experience in Clinical Data Analysis, Producing Reports, Listings, Tables, Summaries and Graphs from clinical trial data of Clinical Trials.
• Considerable experience with the preparation of SAS datasets and generation of ad - hoc reports, tables, listings and graphs according to guidelines lay down in Statistical Analysis Plan (SAP), Standard Operating Procedures (SOP) and Data Specs.
• Generated tables, reports, listings and graphs for Clinical Study Reports in compliance with 21 Code of Federal Regulations (21 CFR) Part 11, FDA, ICH, and GCP guidelines.
• Proficient in handling in data issues.
• Experience in producing external files and customized reports using various SAS procedures like Proc Report, Proc Print, Proc Means, Proc Summary, Proc Freq, Proc SQL, Proc Transpose.
• Modified existing SAS Macro programs and created new programs using SAS macro variables making the programs more efficient & maintained the consistency of results.
• Experience in Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS) and involved in reviewing the Case Report Forms.
• Creating user defined formats by using Proc Format and Informats.
• Productive self-starter with a strong work ethic; consistently achieve goals.
• An excellent problem-solver, able to quickly grasp complex systems and identify opportunities for improvements and resolution of critical issues.

TECHNICAL SKILLS

SAS Procedures: Tabulate Report, Print, Contents, Means, Freq, Univariate, Summary, Format, Chart, Gpolt, Sort, Transpose, Anova, Regression, and Compare

SAS Tools: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/CONNECT, SAS/GRAPH, SAS/ODS, SAS/ENTERPRISE

Operating Systems: UNIX, WINDOWS 95/98/2000/NT, MS-DOS, Open VMS

Applications: MS Office 97/2000/XP, MS Excel, Power Point, MS Word

PROFESSIONAL EXPERIENCE

Confidential - Durham, NC

Sr. SAS Programmer

Responsibilities:

• Developed standard reports for safety data including adverse events summaries.
• Developed and maintained existing SAS programs that were used for creating various reports, lists, etc. for regulatory submissions.
• Developed data specification for Phase I and III clinical trials
• Generate the required SAS datasets from large database using Sorting and Merging techniques.
• Proc SQL, Proc Import was used to retrieve data from databases like Oracle and Excel.
• Reports were updated weekly or monthly based on schedule using SAS - output delivery system ODS.
• Maintained appropriate study application documentation. Provided SAS programming and statistical support to Clinical studies
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Accessed External Excel files, Stored and Retrieved SAS data sets moving data through multi platforms.
• Responsible for developing new SAS programs and modifying existing SAS programs.
• Converted MS-Excel, text files and into SAS data sets.
• Wrote Edit Check programs for analyzing data before using for final analysis.
• Developed reports using PROC REPORT and DATA NULL .
• Involved in creating DEFINE.XML.
• Created Ad hoc reports for Listings, Tables, and Figures.
• Creating Summary Reports and Tabular Reports. Used SAS/STAT software for Statistical Analysis, procedures and reports.

Confidential

Clinical SAS Programmer

Responsibilities:

• Successfully implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I to Phase III Clinical Trials data.
• Proficient in handling the input data sets, sorting and merging techniques to get the required report.
• Developed and maintained programs in SAS using SAS tools for Windows and UNIX.
• 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 like SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL.
• Involved in preparation and interpretation of Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS), Confidential and NDA application for FDA submission.
• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/Base and SAS/Macro facility
• Produced quality customized reports by using PROC REPORT and PROC SUMMARY and also provided descriptive statistics using PROC Means, Frequency and Univariate.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.

Confidential

Clinical SAS Programmer

Responsibilities:

• Participated in reviewing, designing and annotating CRFs, edit check specifications, mock shells for tables/listings/figures.
• Created SAS programs to generate tables, listings and figures for inclusion in Clinical Study Reports, annual safety reports and other documents, as requested.
• Identified data issues and reported findings to the appropriate team members
• Converted Existing Raw data into SDTM datasets using CDISC SDTM standards.
• Created SDTM and ADaM datasets as per CDISC standards for Phase-I -III clinical trials.
• Created specification documents for creating SDTM and ADaM dataset variable based on study requirements
• Supported in creation of ISS datasets, tables and listings
• Interacting with other members of the Biostatistics & Statistical Programming team and with other groups, such as Data Management to ensure a high level of client satisfaction and successful execution of projects
• Performed edit checks to find invalid data or data entry issues in the raw data.
• Collaborate with the lead statistician on generating/finalizing analysis specs.
• Used Output Delivery System (ODS) facility to write custom ISS directing SAS output to RTF files.
• Provided Quality Control (QC) programming support by developing programs for comparing them with source programmer's code.
• Maintained effective communications within Biostatistics and the Data Management group for requirements gathering and report finalization.
• Data checksto ensure integrity and correctness of data displays while gaining an understanding of structure and content of data
• Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) for clinical trials.
• Met timelines & communicated issues to the lead statistician effectively and proactively.