SUMMARY:

• 7+ years of experience in Statistical programming using primarily SAS and creating, analyzing, reporting data in Pharmaceutical, Healthcare and CRO Industry.
• Strong experience on SAS - BASE, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/ODS, SAS/MACROS, SAS/ODS, SAS/GRAPHICS, SAS STUDIO and SAS/SQL in Windows, UNIX and LINUX Environment.
• Knowledge on drug development process and hands-on experience in handling studies from phases (I - IV) and handled Oncology Survival Studies, Cardiovascular Observational and Cohort studies, Real World Evidence (RWE), PK, PD, Scintigraphic, Radiolabelled, ivMicrotracer and many others.
• Have Good experience in leading multiple studies, performing Study Startup activities, assigning tasks, managing study teams and also analyze resource needs/time depending upon requirement.
• Experience in authoring, reviewing Statistical Analysis Plan (SAP) and other documents including Programming Validation, Data Edit Checks, POA, Statistical Programming Guidelines and Work SOP’s.
• Accountable for Statistical Programming, Project Regulatory Submissions Set up External Client and Internal meetings on regular basis to discuss various Data/Stats reporting related issues.
• Actively involved in FDA Approval, NDA, DSMB, BDRM, ISS/ISE and CSR submissions for various Late-Phase studies and submitted deliverables within timelines and as per Regulatory Standards.
• Generated SDTM, ADaM datasets and developed dataset Specifications as per CDISC-SDTM/ADaM Guidelines.
• Liase with Clinical Data Manager/Database Management Staff to discuss any database level issues for smooth ongoing of the Programming.
• Production of TGL’s of Safety and Efficacy Statistical Outputs involving Demographics, Baseline Characteristics, Exposure, Survival Plots, Time to Event Changes, Risk Profiles, Lab and Adverse Events, Shift Tables, Mortality rates, Overall Health scores and Endpoint Evaluation and many others on regular basis for either Final Analyses or ADHOC Analysis.
• Performed Data Validation, Edit Checks and developed QC Programs/Macros on programmed analysis datasets, efficacy and safety TFL’s for data consistency.
• Extensively created Study specific Macros and understand Sponsor specific macros.
• Trained in Good Clinical Practice (ICH GCP), Regulatory Compliance such as ICH-E3, ICH-E9 and 21 CFR Parts 11 and Regulatory Rules.
• Designed several ETL jobs using SAS DI Studio to port the ODS data into data marts with tasks involving configuring metadata libraries in SMC, developing transformation logic and staging the final data.
• Worked in Enterprise guide programs for report generation and data analysis.
• Experience in DataMart/Database remodeling - using MS Visio identifying new relationships and creating Primary and Foreign keys; enhancing existing relationships, reducing number of tables, views, joins for denormalization.
• Skilled in analytical and business reporting using SAS, MS Office, VBA and RDBMS technologies.
• Mentored junior level SAS Programming staff and provide technical assistance as and when needed.
• Involved in preparing Integrated Safety and Efficacy reports, FDA Submissions and created Define.XML, PDF and transport files.
• Maintenance of large data structures, testing, validating, extracting, combining data from various sources in varying formats.

TECHNICAL SKILLS:

Tools: SAS/BASE,SAS/MACRO,SAS/SQL,SAS/ACCESS, SAS/ODS,SAS/GRAPH.

SASDI Tools: SAS STUDIO,SAS/EG

Business Intelligence: SASManagement Console,SASEnterprise Guide, SKI, SASData Integration studio, Visual Studio, SASInformation Map Studio,SASWeb Report Studio

Operating Systems: WINDOWS, UNIX.

Database: Oracle 9i/8.x, DB2, Teradata, MS SQL Server.

Languages: SQL and PL/SQL.

PROFESSIONAL EXPERIENCE

Confidential, West Hartford, CT

SASProgrammer/Analyst

Responsibilities:

• Developed programs using the Libname statement &SAS Views to extract & report error statistics
• Developed the Spectrum Business Credit Score application. Calculated the coefficient factor using selected Experian Credit data elements to derive the business risk score.
• Updated business specifications, created system flow charts and prepared test plans.
• Used Excel templates and VBA to generate custom reports from data in SAS tablesTo provide analysis of healthcare and prepare analytics that will provide insight into trends and forecasting
• Decreased disk space by using SAS Visual Analytics results in minimizing the server cost
• Imported data from SQL Server and Excel to SAS datasets. Performed data research forecasting models into production by using Base SAS, SAS Macros, PROC SQL and many other SAS tools
• Assisted architecture team in moving layers of the EDW from Oracle to Teradata for using SAS In Database technology
• Developed SAS/MACRO to concise code for data cleaning and reporting and also to standardize the report and chart generation for re-use with PROCTABULATE, PROCREPORT, PROCAPPENDPROCGPLOT, and PROCGCHARTetc
• Analytical function applied across data in multiple sources (Hadoop, Teradata and Excel).
• Utilized VisualAnalytics to help the executives in Decision Support System(DSS)
• Wrote Teradata code / SQL to enable the ETL processes to meet demanding business requirements, including BTEQs, Fast Loads, Multi Loads, and Fast Exports
• Involved in establishing connections to different data sources (SQL Server, Vertica, Teradata, SAP, Salesforce, Azure Cloud, and web site data) and pulling relevant data from these source systems for data modelling.
• Used Visual Analytics for Report Viewing, Analysis, Data Building and Reporting.
• Workedin Decision Support Informatics (DSI) and HealthCare Effectiveness and Data Information (HEDIS), Center For Analytics (CFA) teams for Technical and Analytical inputs
• Executed data validation Stored Procedures in SSIS Packages in Business Intelligence Development
• Studio (BIDS) and performance tuning of Stored Procedures and T-SQL Queries.
• Created SSIS packages to extract data from OLTP to OLAP systems and scheduled jobs to call
• Performed detail analytics while producing financial reports so that the financial data is checked and are accurate

Environment: SAS 9.1 SAS/STAT, SAS/MACROS, Oracle, SQL, PL/SQL, Microsoft office 2003/2007, Excel, Windows XP, And UNIX

Confidential, MN

SAS Programmer

Responsibilities:

• Worked in SAS PC for design, development and operations.
• Perform data extraction from various sources
• Performed quality control, as required per SOPs, for statistical programming deliverables (including input in Validation Plan & QC documentation)
• Provided items required for e-submission (i.e. SAS transport files, define.pdf, annotated CRF)
• Created derived-analysis datasets for the biostatistician based on SDTM/Adam standards.
• Assisted in providing and maintaining project plan for all projects/study including milestones, tasks, and coordination of programming activities
• Executed analyses specified in the Statistical Analysis Plan (SAP) under the guidance of the project statistician
• Secondary programmer to validate SAS programs that produce derived-analysis datasets and data analyses.
• Designed, developed and tested SAS code to track and forecast the sample and lab test results.Developed code to track patients’ end of study visits and early termination.
• Tested the macros to track error handling and email notification due to system failure. Produce frequency and distribution tables for various studies for analysis.

Environment: SAS 9.1.3, SAS DIS, SAS EG 4.0, SAS/Base, SAS/Macros, SAS/Access, SAS/CONNECT, SQL, Oracle, SQL Server, Windows OS

Confidential, Philadelphia, PA

SAS Analyst

Responsibilities:

• Collaborate with physicians, medical writers and data managers to finalize mock tables
• Design; select appropriate SAS procedures for each statistical analysis; test-run SAS program on mock data to ensure smooth analysis implementation.
• Use PROC SQL/IMPORT to import data from mainframe oracle clinical databases and MS excel sheets.
• Perform Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/OR, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.
• Produce quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provide descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE.
• Work with statistician to analyze the results obtained from various statistical procedures like Chi-Square, PROC ANOVA, GLM, and T-test.
• Develop and debug routine SAS macros to create tables, graphs and listings.
• Provide proper validation, including testing and documentation (e.g., requirements document, program validation), in accordance with GCP and company standards.
• Contribute to the development of manuscripts, labels, scientific and commercial presentations, and regulatory response documents by generating statistical tables and graphs through SAS programming.

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/OR, SAS/STAT, SAS ETL, SAS/Enterprise Guide, SAS Data Integration, Excel, Windows, SPSS, Oracle.

Confidential

SAS Developer

Responsibilities:

• Use of SAS Macros to modify hard coding in existing programs into Automatic process through an excel sheet.
• Unit tested the results between Pre and Post changes.
• Generated reports validating changes between pre and post modifications.
• Extensively used PROC SQL for column modifications, field populations on warehouse tables.
• Generated output files in text format, HTML & PDF format using SAS ODS.
• Retrieved surplus records from DB2 by connecting to the remote server using FTP and retrieved data.
• Modified tables in warehouses according to business user requirements using SAS/BASE and SAS Macros.
• Worked with several SAS procedures like FORMAT, FREQ, MEAN, PRINT, and SORT for data validation, cleansing, analysis and reporting purposes.
• Working with production support issues.

Environment: SAS BASE, SAS/SQL,SAS/OR,SAS Macro, SAS/ACCESS, SAS/ODS