SUMMARY:

• 10 + years of highly experienced SAS programmer/Analyst in health care, insurance and pharma industries.
• Fluent with the applied aspects pertaining to SAS Programming using SAS/Base, SAS/Access, Macro, SQL, SAS/Connect, SAS/Enterprise Guide, SAS/Stat & SAS/Graph.
• Experienced with MS Excel functions that include working with large data sets, creatingstandardized reports, utilizing vLookups and advanced functions/ formulas, creating, using and interpreting pivot tables, filtering and formatting
• Worked with SAS and/or SQL creating queries, pulling large data sets and performed data manipulations/analysis.
• Worked on phase I Phase II and Phase III of clinical trials and their designs including open - labeled, single blinded, double blinded, randomized, parallel, crossover and sequential studies.
• Good knowledge of GCP, GPP and US FDA & CFR Part 11 guidelines related to generating the Clinical Reports and Electronic records as well. Experienced in Preparing FDA E-submission ready reporting documentation including creating DDT’s, Transport files (XPORT format files).
• Experience involved in Statistics and contribution of end to end SAS programming activities data processing, data collection, quantitative and qualitative analysis (encompassing extracting data from Clinical trial into SAS as datasets to producing the reports viz.).
• Good understanding of regulatory requirements, ICH Guidelines, NDA processes, from IND submission to FDA approval (in compliance with 21CFR Part 11). This includes Clinical Trials (Phases I-IV), preparation of IND, NDA, safety reviews, adverse event report reviews and production of integrated safety and efficacy summary (ISS & ISE) for FDA submission.
• Excellent skills in statistical analyses and modeling, familiar with common statistical methods for clinical research and Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials.
• Experience in survival analysis by using procedures like PROC LIFETEST (KAPLAN MIER), LIFEREG, PHREG, LOGISTIC.
• Experience in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs; Performed Data Analysis validation and Created the programs to as per the specifications required to run in the SAS drug Development (SDD).
• Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macro to improve ease and speed of modifications as well as consistency of results.

TECHNICAL SKILLS:

SAS Skills: v 8.0/9.0/9.1/9.2, SAS/BASE,SAS/STAT,SAS/MACROS,SAS/GRAPH, SAS/SQL, S-PLUS, SAS Enterprise Guide, SAS Enterprise Miner, SAS DI Studio, SAS Web report studio, SAS Metada Security, SAS procedures, SAS BI, Open CDISC validation.

Other Skills: SPSS,R, Qlikview, Sudaan, Strata, S-Plus, MINITAB,MATLAB,ETL tools, ODBC, health analytics using business intelligence tools, Data Warehousing, Data Mapping, SharePoint, Sigma Stat, Sigma Plot, MS Office (Power Point, Excel, Access, Word), MS Visio, MEDDRA, ICD-9,ICD-10, COSTART, Crystal reports, EPIC Bridges,HL7, Sarbanes-Oxley, HIPAA.

Databases: RAVE, Oracle Clinical, MYSQL, MS SQL Server, MS Access, Oracle 11i, DB2.

Languages: C,C++, Visual Basic,JAVA, VBScript, XML, T-SQL,SQL, PL/SQL, VB.NET, ASP.NET, PERL,HTML, PHP, Web CGI.

Operating Systems: Windows95, 98, NT/XP/2000, DOS, Mainframe, UNIX.

PROFESSIONAL EXPERIENCE:

Sr. SAS Programmer Tech Lead

Confidential, Waukegan, IL

Responsibilities:

• Developing SAS code for tool developmentusing SAS Macro and PROC SQL, with extensive and applied CDISC knowledge in SDTM and ADaM.
• Expertise in developing datasets with current knowledge, guidance and concepts of SDTM: ex: RELREC, SUPPQUAL, CO domain and generate Define.XML.
• Developed macros ex: co derive, BLFL for sdtm load.sas program, execute, test and deploy.
• Point of contact for Primary development and unit testing of SDTM and ADAM detailed design and deployment.
• Used SDLC methodologies, from developing code till deployment.

Senior SAS Programmer Tech Lead

Confidential, Los Angeles, CA

Responsibilities:

• Created SAS programs for data mining for oncology study.
• Gathered study team requirements and translated them into technical specifications for SAS programs
• Programs for SAS data validation checks and listings to identify data discrepancies
• Programmed SAS checks to integrate and reconcile data from external sources ie, RAVE database (including serious adverse events (SAE), lab results, ECGs, electronic patient records, medical devices and interactive voice response (IVR)) into the primary clinical database SAS datasets
• Review Case Report Forms and formatting of SAS datasets extracts for accuracy and consistency
• Provide programming support for Annual Safety Reports and Publications
• Build standard SAS Macro library
• Mentor junior level SAS programmers
• Provided Ad hoc statistical programming support
• Created and validated ADaM datasets from SDTM datasets as input, implementation guide and company standards.
• CreatedADAM datasets and table programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA.
• Worked on CRF Annotations, SDRG, ADRG, define.pdf and define.xml for FDA submission

Confidential, Princeton, NJ

Senior Statistical Programmer/Analyst

Responsibilities:

• Worked on phase I, II and III clinical trial studies.
• Creation and validation of SDTM data sets from raw data by following SDTM annotations, implementation guide and company standards.
• Creation and validation of ADaM datasets from SDTM datasets as input, implementation guide and company standards.
• Reviewand proved effective feedback on Protocol, eCRF, database design, Data Presentation Plan (DPP), SAP and TLF shells.
• Creation and validation of Tables, Listings and Graphs by following protocol, SAP and shells as per industry and company standards for regulatory submissions.
• Extensively used PROCMEANS, PROC FREQ, PROC ANOVA, PROC MIXED, PROC REG, PROC UNIVARIATE to create outputs based on SAP and shells for statistical analysis of clinical trial data.
• Assisted in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
• Used efficient programming techniques to produce and QC derived datasets, tables, figures and data listings.
• Developed and maintained general-purpose and adhoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Formatted HTML and RTF reports, using SAS/ODS - output delivery system
• Produced Tables, Listings and Graphs from Integrated data of different studies for Integrated Summaries of Efficacy (ISE) and Safety (ISS) clinical studies.
• Coordinated statistical programming team to successful completion of a study within given timelines and resources.
• Extract and validate raw data from Excel file, Access, and Oracle Relational Database by SAS/Base and SAS/Macros
• Create complex and reusable Macros and extensively used existing macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis, and Report generation.
• Created SAS transport files for Electronic Submission
• Retrieve clinical and lab data from Oracle database and generate SAS datasets.
• Reviewed of Clinical data for FDA Submissions
• Environment: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL, HTML and UNIX.

Confidential, Wayne, PA

Senior Statistical Programmer/Analyst

Responsibilities:

• Developed the macros to automate the report process.
• Worked with ETL/BI Reporting Handling projects planning and priority management.
• Worked on testing a reporting tool to increase productivity with quality.
• Program, analyze and evaluated data using SAS
• Assist Data Management in assuring data integrity
• Built new MACROS and modified existing MACROS to produce customized reports
• Data transmission and integrity check of the SAS dataset
• Wrote code using SAS/BASE and SAS/MACROS to extract data from ORACLE and MS ACCESS databases.
• Using SAS ACCESS defined the oracle database to ODBC to retrieve the data
• Produced quality customized reports using PROC REPORT, PROC TABULATE and SAS/ODS.
• Provided descriptive analysis using PROC MEANS, PROC FREQ, PROC SORT and PROC UNIVARIATE.
• Combined and Modified SAS datasets for statistical analysis using SAS data step and procedures including PROC SQL
• Supported Staff programming needs and performed Ad hoc requests.
• Environment: SAS, SASEG, Cognos, Report net, DB2, ERWIN, Informatica, Excel, Microsoft Project, Oracle, Powerpoint, SQL, SQL Assistant, Teradata, Teradata administrator, Teradata utilities, Tivoli, Unix (Korn shell scripting ), Visio, word.

Confidential, Newark, NJ

SAS Programmer/ Analyst

Responsibilities:

• Worked with Health care data which includes membership details and various claims of the members.
• Gathered data from Oracle, SQL Server and reporting requirements from business.
• Extracted data from oracle database using SQL pass- through facility.
• Developed Oracle PL/SQL triggers and procedures. Set up Oracle PL/SQL package to analyze the tables and indexes, records tables and rebuild indexes.
• Created database objects, tables, indexes, writing procedures, SQL scripts.
• Created complex and reusable Macros and used existing macros for Data Cleansing, Validation analysis and Report generation.
• Provided statistical programming expertise in production of high level Reports using proc report.
• Comprehensive skills in working with SAS/BASE, SAS EG, SAS EBI, SAS/MACRO etc. in windows and UNIX environment.
• Prepared detailed summaries and reports for the pharmacy and health claims data using SAS Data step and various statistical procedures like proc sql, proc summary, proc report, Proc Tabulate, ODS statements and Proc Template to generate output formats in HTML Excel and RTF.
• Performed QC and Edit Checks using various procedures and Macro facility, coded Independent Programs for validation of analysis dataset.
• Used putty to communicate with the data on the Unix server, wrote Unix commands to tar, zip, unzip files and move files from one to other directory etc.
• Extensively used of SAS Macros in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Revised and automated daily, weekly, monthly and quarterly reports to run more efficiently and provide more meaningful information vital to the overall strategies.
• Performed Pharmacy Claims data analysis for in-network/out-of-network claims.
• Performed Pharmacy/Health enrollment analysis and reporting.
• Performed Participating/Non-participating provider data analysis.
• Performed pharmacy claims data extraction and analysis to produce reports evaluating the potential financial impact associated with implementation of medical policy claim edits.
• Extensively Used Data Null techniques for producing highly formatted and highly customized reports.
• Coordinated the production of monthly, quarterly, and annual performance reports for senior management.
• Created and used multiple SAS stored processes to generate high level summaries with conditional highlighting through SAS code by using call define statements in proc report.
• Environment: SAS EG, SAS/BASE, SAS/MACROS, SAS/ACCESS,SAS/SQL, DB2,Oracle, MS SQL, Unix.

Confidential, Bloomfield, CT

SAS Programmer

Responsibilities:

• Worked as part of the Clinical Insights and Disease Management group at CIGNA to manage Oncology.
• Worked on Health Care databases: HCE (Health Care Economics), Pharmacy, Carve Out Pharmacy, GILA (Utilization Management), NDC (National Drug Code), JCodes and HRA (Health Risk Assessment).
• Extracted data from DB2 tables to SAS datasets. Merged and manipulated data after importing to SAS.
• Worked on MVS operating system/ IBM Mainframe to extract data and exported some datasets to PC SAS. worked on analysis of JCL scripts for IBM MVS Mainframes to understand different Procs and Jobs executed.
• Used Procedure Code and Diagnostic Codes to stratify different types of Cancers. Worked on the Oncology program from design, development and testing.
• Used Proc Summary, Proc Transpose, Proc SQL and merging extensively. These programs are for HMO and PPO .
• Worked with applications to generate presale reports in Oncology.
• Worked on screenings for different types of cancers like Breast, Colorectal, Cervical, Prostate and Mammograms along with quality metrics.
• Environment: SAS EG, SAS/BASE, SAS/MACROS, SAS/ACCESS,SAS/SQL, DB2,Mainframes.