SUMMARY

• Experience in Analysis, Design, Development and Validation of Datasets
• Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines
• Strong knowledge involving in all phasesof clinical trials in various therapeuticareas
• Good working knowledge on clinical trial data like Safety and Efficacy
• Executed projects on BASE/SAS, SAS/MACROS, SAS/STAT, and SAS/SQL in Windows and UNIX environment
• Extensive exposure to SAS programming in merging SAS data sets, macro facility, producing reports and SAS formats
• Experienced using industry standards for database design as defined by Clinical Data Interchange Standards Consortium (CDISC).
• Knowledge of industry practices withCDISC Standards,SDTM, ADaM and TDM (Trail design model) experience.
• Optimizing SAS IO
• Co - ordinating with SAS Tech supports
• Packaging of Virtual apps for SAS Clients
• Supported SAS Clients for Windows 7 migration
• Involved in the process of generating Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA Submission.
• Maintenance of large data sets, combining data from various sources in varying formats to createSASdata sets
• Generated ad-hoc reports for raw datasets using Print and Report procedures
• Familiar with ICH, GCP and 21 CFR part 11 guidelines and Electronic Submission standards.
• Worked on Pooling of safety and efficacy datasets
• Operating System Administration
• Worked on data monitoring committee(DMC) and risk management plan(RMP) submissions

TECHNICAL SKILLS

SAS Tools: SAS/BASE, SAS/GRAPH, SAS/MACROS, SAS/SQL, SAS/STAT and SAS/ANALYST and SAS/ETL, SAS 9.1, SAS/ACCESS, SAS/ODS, SAS/GRAPH

Tools: MS OFFICE, ACCESS

Operating Systems: Windows and UNIX

Languages: Core Java, VB, HTML

Database: Oracle 8i, SQL server2000

PROFESSIONAL EXPERIENCE

Confidential, NC

SAS Programmer/Administrator

Responsibilities:

• Performed Analysis on complex claims within the Processing System.
• UsedSAS/Assist to extract data fromSASFiles and Oracle Data base.
• Developed Stored Processes to distribute reports in a secure manner.
• Created reports in the style format (RTF, PDF and HTML) usingSAS/ODS.
• Effectively prepared and published various performance reports and presentations.
• Documented the Business requirements based on HIPPA compliance rules.
• Worked with complex datasets to extract customized reports using PROC SQL, PROC FREQ, PROC SORT, PROC REPORT and PROC MEANS for creating a preferred list of customers as per the given requirements from business analysts.
• Performed Data analysis, mainly using Regression and ANOVA (Proc REG, Proc GLM, and Proc ANOVA).
• Required strong knowledge of ICD-9, ICD-10 codes.
• Generated SQL reports and Business Objects reports to maximize system capabilities for tracking and reporting information.
• Prepared and monitored progress on system changes requests.
• Created and maintained inventory reports.
• Involved in writing code using BaseSAS&SAS/Macros to clean and validate data from oracle tables.
• Installation/Migration of SAS Software
• Packaging of Virtual apps for SAS Clients.
• Conducted data investigation usingSASEnterprise Guide.
• Co-ordinating with SAS Tech supports.
• Involved in Data mining using Enterprise Miner for various health care datasets such as Eligibility, Inpatient, Outpatient, Long Term Care and Pharmacy (Rx).
• Prepared claim status reports for department.
• Worked closely with Team Members to ensure that problems were resolved timely, and results of analysis was documented and shared with the team and departments.
• Reviewed existing literature on Medicare, Medicaid and models dealing with Medicaid fraud.
• Attended various seminar presentations on Medicaid fraud such as finding duplicate claims, service after death, multiple service providers etc.

Confidential, NJ

SAS Programmer/Analyst

Responsibilities:

• Data processing and validations extensively done usingSASdatasets.
• Involved in standardizing reporting procedures for graphical and tabular reports.
• Building permanentSASData sets involving different forms of data.
• Used differentSAStechniques including sub setting, conditions, formatting etc.
• Worked on variousSASprocedures to achieve the required functionality
• Reports various health care management metrics such as Number of readmissions, Patient category metrics, Patient demographics, Service delivery and drug utilizations etc.
• Research characteristics associated with member utilization patterns, self-care habits, and health behaviors.
• Used advancedSAStools automate the reporting systems to generate daily and monthly reports.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Majorly worked with the data management team and was involved in handling documentation and submission processes
• Define department specific report requirements, profile data and develop data quality definitions.
• Conducted end user training for basic and advanced reporting skills.
• Creation of Universe Objects as per the Users requirements
• WroteOutput delivery systemSASprocedures to publish reports as HTML pages to the web.
• Used procedures like PROC FREQ, PROC MEANS, PROC SORT, PROC PRINT PROC TABULATE, PROC UNIVARIATE and PROC REPORTS.

Confidential

Regulatory SAS Programmer

Responsibilities:

• Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like NDA and Safety.
• Developed programs for validation of tables and listings for clinical study reports according to CDISC standards.
• Setting up SAS datasets by extracting data from Oracle Clinical using PROC ACCESS, SQL Procedures Pass-through facility and Oracle Libname Engine.
• Created and maintained SAS datasets that are extracted from Oracle databases using SAS DATA STEP and PROC SQL.
• Used Sorting and Merging techniques on the raw data sets for value added data reparation, to get the required Reports or Analysis data sets.
• Produced Ad-hoc reports as per requests.
• Developed and updated existing MACRO programs.
• Modified SAS Macros related to multiple studies.
• Involved in the support of Phase II and III clinical trials; Regulatory submissions.
• Worked on the safety (ISS) and efficacy (ISE) listings for the various studies, contributed to the development of standard operating procedures (SOPs).
• Created CRT (Case Report Tabulations) datasets using ODM model of CDISC standards for FDA/Global Submission.
• Used SAS ODS to generate the reports in RTF and EXCEL formats.
• Worked on multiple protocols and/or drug compounds at a time.
• Conducted analysis on the raw data to determine the quality and validity of data.
• Review of specifications, mock-up tables.
• Maintained appropriate study application documentation.
• Used Base SAS & SAS Macros to generate reports of clinical data and assisted in the validation of clinical data from Clintrial or other electronic sources.
• Performed QC (Quality Check) extensively on tasks performed by other team members and involved in data validation and data cleaning in all phases of Clinical studies.
• Program documentation on all programs, files and variables was performed for accurate historical record and also for future reference.