TECHNICAL SUMMARY

• Over 7 years of 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 therapeutic areas
• 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
• Coordinating 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 create SAS data 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

Tools:

• 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

Role: SAS Programmer

Responsibilities:

• Performed Analysis on complex claims within the Processing System.
• Used SAS/Assist to extract data from SAS Files and Oracle Data base.
• Developed Stored Processes to distribute reports in a secure manner.
• Created reports in the style format RTF, PDF and HTML using SAS/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 Base SAS 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 using SAS Enterprise Guide.
• Coordinating 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

Role: SAS Programmer/Analyst

Responsibilities:

• Data processing and validations extensively done using SAS datasets.
• Involved in standardizing reporting procedures for graphical and tabular reports.
• Building permanent SAS Data sets involving different forms of data.
• Used different SAS techniques including sub setting, conditions, formatting etc .
• Worked on various SAS procedures 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 advanced SAS tools 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 system SAS procedures 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

Role: Regulatory SAS Programmer

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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.