SUMMARY

• Over 4 years of experience in SAS emphasizing on analysis, design, development, testing and implementation for pharmaceutical industries.
• Proficient with SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS MACROS and SQL.
• Good experience in Phase I to Phase IV Clinical Drug Trail studies. Understanding of clinical trial practices, procedures and methodologies.
• Experience in generating SAP, Tables, Listings, Graphs, Documentation, FDA and NDA Electronic submissions.
• Experience in producing reports employing various SAS procedures like PROC SQL, PROC REPORT, PROC FORMAT, PROC TABULATE, PROC FREQ, PROC MEANS and PROC UNIVARIATE, PROC SUMMARY.
• Experience in producing HTML, RTF and PDF formatted files using SAS/ODS.
• Knowledge of CRT Dataset Creation, CDISC and MedDRA standards for regulatory submissions.
• Knowledge of CRF - Annotation with respect to various database designs in clinical trials for pharmaceutical industries.
• Experienced in producing RTF, PDF, HTML files using SAS ODS facility.
• Excellent programming skills in SQL and understanding of data management principles, such as joining data sets, data aggregation and subsetting using PROC SQL.
• Extracted Data from various sources, transformed data and loaded data in to Oracle Tables by using ETL.
• Prepared SOPs of SAS Programming standards, SAS Validation, CDISC SDTM standards
• Good experience using Graph SAS procedures.
• Strong ability to manage and manipulate databases, program and generate reports according to user needs.
• Highly organized and dedicated with a positive attitude and self motivated. Good written, oral, and interpersonal communication skills.
• Experience in extracting data and creating SAS datasets from various sources like Oracle database, Access database, Excel and flat files using SAS/ACCESS and other Import techniques.

TECHNICAL SKILLS

SAS Skills: SAS v8, v9.1, SAS/BASE, SAS/MACRO, SAS/SQL, SAS/Graph, SAS/STAT

Design Tools: MS Office 97/2000/XP, MS Excel, Power Point, MS Word.

O/ S: Windows-98/2000/XP/NT and UNIX.

PROFESSIONAL EXPERIENCE

Sr. SAS Programmer

Confidential, Winston-Salem, NC

Responsibilities:

• Produced analysis datasets for generating Reports.
• Created and maintained SAS Datasets extracted from Database.
• Created Tables, Listings, Graphs and customized reports using various procedures like Proc Report, Proc Tabulate, Data null and Proc Gplot.
• Wrote SAS programs that produce standard reports, such as AE, DM, PE, CM, MH, VS reports.
• Mapping of Raw Data to SDTM data i.e. Generating SAS programs for creating SDTM domains.
• Validated SDTM SAS datasets using SAS QC Macros. Finally converting them into Transport files.
• Involved in writing the SAS code to help in the process of Quality control by implementing various statistical procedures like Proc Freq, Proc Means, Proc Univariate and other procedures like Proc Summary, Proc Transpose, Proc SQL and Proc Print.
• Extensively used SET, MERGE, UPDATE statements and Proc SQL for adding new variables or observations, creating subsets or modifying datasets.
• Produced RTF, PDF and HTML formatted files using SAS/ODS.
• Documented data sets using specifications worked out in conjunction with senior manager.
• As a clinical data associate performed UAT on EDC Software and reported the edit checks.
• Wrote SAS Programs for the edit checks that were detected manually.
• Performed validation of SAS-generated output (tables, listings and graphs) via independent programming. Also performed QC checking and validation of SAS programs written by other programmers.
• Used the SAS Macro facility to modify existing departmental macros and to replace repetitive codes.
• Involved in CRF review, SAP development, Protocol development and review of TLG
• Participated in team meetings to discuss best programming practices. Established and maintained sound working relationship and effective communications within Biostatistics, Statistical Reporting, and the Data Management group.

Environment: SAS v9.1, SAS/BASE, SAS/GRAPH, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/ACCESS, UNIX, LINUX, Windows XP and oracle.

SAS Programmer/ Clinical Data Associate

Confidential, Eagan, MN

Responsibilities:

• Performed data analysis and statistical analysis using SAS/Base, SAS Macro and other procedures like Proc freq, Proc Univariate and Proc Means.
• Reviewed SOP’s and Report Forms to identify irregular data entry errors of health care data. Created safety and efficacy customized reports for FDA regulatory submissions.
• Extracted data from various database sources like Oracle using Proc SQL passthrough facility and SAS/ACCESS libname statements.
• Created SAS Proc sql code to transform the original datasets to target datasets for complex requirements using ETL process.
• Validated/QC’ed other programmers output datasets before loading into final database.
• Effectively used many SAS functions like SCAN, SUBSTR, TRIM and applied strategic logic on data using INTCK, INTNX, SUM, SQRT, STD and VAR.
• Used Dynamic Data Exchange and Proc Import for inputting data from Excel sheets.
• Involved in creating transport files to move files between different environments.
• Incorporated health care specific terms for Event reporting. Performed Ad-hoc Programming for generating multiple reports in HTML and PDF formats.
• Generated primary and derived secondary sas datasets, identified inconsistencies and problems in the database and reported the findings to the appropriate data management department personnel.
• Effectively and timely contacted Project Manager of the respective studies about the various Data Issues and resolved the queries through meetings.
• Ensured leadership in the planning and communication of programming requirements, Analysis, testing & QC and release of code in to Production for generating multiple reports and tables.

Environment: SAS v8, SAS v9, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACROS, SAS/SQL, SAS/ACCESS, SAS/ODS, Oracle 9i Windows XP,UNIX.

SAS Programmer

Confidential

Responsibilities:

• Successfully designed and implemented protocols for regular data collection and clinical data analysis.
• Participated in coding, testing, debugging and documenting SAS Programs and Macros
• Collaborated with Biostatisticians to develop case report tabulations.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Created complex and reusable Macros and extensively used existing macros
• Developed SAS Programs for Data Cleaning, Validation, and Analysis and Report generation.
• Tested and debugged existing macros.
• Computed several ad-hoc reports for safety and efficacy of the clinical studies, as per the specifications that were provided by the Statisticians.
• Conducted, documented and reported Data Validation inspection in compliance with FDA Regulations and other regulatory compliance.
• Formatted HTML, RTF and PDF reports using SAS output delivery system.

Environment: SAS/BASE v8, SAS/ACCESS, SAS/SQL, SAS/STAT, SAS/GRAPH, Windows, UNIX and MS Excel.