SUMMARY SAS Base Certified Programmer for SAS 9 - SAS Institute SAS Programmer with 6+ Years of IT Experience in SAS programming and experience in planning, collection, management, analysis of clinical trial data to ensure complete integrity of the data. Designing, development, testing and implementation of Clinical Trial Projects in Pharmaceutical industries. Experience in SAS/BASE, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS and SAS /ODS in Windows and UNIX environments. Extensively used PROC SQL, SAS/ACCESS to extract data from different data sources into SAS Datasets. Experience in preparation ofSASdatasets, Tables, Listings, Graphs, Reports, Output Delivery System (ODS) and Summaries according to requirements, Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP). Good Understanding of Clinical Trial protocol and CRF’s and participated in Review of annotated CRF’s. Developed programs inSASBase for converting the Oracle Data for a phase I - IV study intoSASdatasets using SQL Pass through facility and Libname facility. Knowledge of complete new drug & device release process from IND (pre-clinical) submission to FDA approval, which includes Clinical Trials (Phases I-III), preparation of IND, NDA, safety reviews, adverse event report reviews, risk factor, integrated safety and efficacy summary (ISS & ISE) for FDA submission. Development of study specific SAS Macros. Experience in Data Manipulation procedures such asSASFormats/Informats, Merge, Proc Append, Proc Datasets, Proc Sort and Proc Transpose Has great understanding and working knowledge of Good Clinical Practice (GCP), Good Programming Practice (GPP), Code of Federal Regulations (21 CFR part 11), FDA regulations and ClinicalTerminology. Good exposure to various Therapeutics areas like Diabetes, Cardiovascular, Oncology, Neurology, Dermatology and Osteoporosis. Knowledge of industry practices with CDISC, CDASH, MedDRA, WHODRUG standards and Models including SDTM, ADaM, ODM. Good knowledge of systems like Medidata Rave, Safety Gateway, WebSDM, Janus, CDISC Suite, OpenCDISC tools used in efficient streamlining of various processes involved in clinical research. Having excellent command in producing reports employing variousSASprocedures like Proc Print, Proc Report, Proc Tabulate, Proc Mean, Proc Freq, Proc Univariate, Proc Transpose, and Data _NULL_ . Strong experience usingSAS/GRAPH to produce Graphs by employingSASprocedures such as Proc Gplot and Proc Gchart. Expertise in transforming data imported from disparate data sources into analysis data structures, usingSASfunctions, options, ODS, array processing, macro facility, and storing and managing data inSASdata files. Experience in creating test scenarios to find errors and confirm programs meet specifications. Program Documentation and Review Experienced in producing RTF, PDF, HTML and MS Excel formatted files usingSASODS facility. Self-Starter and highly motivated towards the job. Ability to adapt to different working environments. Excellent problem solving skills for delivering useful and compact solutions. Always keen and eager to face up to challenges by means of innovative ideas.
SAS Skills: SAS 9.1.3, SAS/BASE, SAS/MACRO, SAS/CONNECT, SAS-SQL, SAS/STAT, SAS/GRAPH, SAS - ODS, SAS/ACCESS.
SAS Procedures: PRINT, TRANSPOSE, CONTENTS, MEANS, CHART, PLOT, PRINTTO TABULATE, UNIVARIATE, SUMMARY, SORT, SQL, FREQ, FORMS, UPLOAD, DOWNLOAD, DATASETS, FORMAT, IMPORT, EXPORT, REPORT, GPLOT, BOXPLOT, XPORT, GCHART AND GLM
Data Bases: MS SQL Server 2008/2005/2000
Languages: BASE/SAS, ORACLE, SQL
Confidential,New York, NY Built Data Warehouses to store all the data pertaining to New Jersey Medicare and New York Complete Care. Created Data transformation and Data Loading (ETL) scripts for Data Warehouses. Modified tables in warehouses according to business user requirements using SAS/BASE and SAS Macros. Documenting of service requests by business users, developed code documentation, logs and outputs documentation, creating Test Plans and Production Release Notices for QC, QA and Production teams to perform further analysis. Extensively used PROC SQL for column modifications, field populations on warehouse tables. Additional responsibilities being Requirements gathering, Designing, Coding and Analysis, Testing, Debugging, Output generations in prescribed formats, extensive documentation of SAS Programs and Macros. Enhancement of scripts for Macros and SCL Frames utilized for standard processes at HealthFirst. Generated output files in text format, HTML & PDF format usingSASODS. Worked with several sas procedures like FORMAT, FREQ, MEAN, PRINT, SORT for data validation, cleansing, analysis and reporting purposes.
Position: SAS Developer May 2012 - present
Environment:SASBASE, SAS/SQL,SASMacro,SAS/ACCESS, SAS/AF, SAS/SCL, SAS/ODS.
Position: SAS Programmer May 2011-Mar2012
Responsibilities: Worked with a team of Bio-statisticians and Data Managers for Generating Safety and Efficacy tables across Phase I, II, and III Clinical Studies. Good exposure to various Therapeutics areas like Cardiovascular, Oncology and Neurology. Generated tables and listings based on CDISC, CDASH SDTM models. Used OpenCDISC to validate the trial data for regulatory submissions. Exposed to Medidata Rave functionalities in regard to capturing, managing and reporting clinical trial data. Performed data analysis, statistical analysis, and generated reports, listings and graphs using SAS tools-SAS/Base, SAS/Macros and SAS graph, SAS/SQL, SAS/Connect, and SAS/Access. Extensively used Proc Export to generate Excel Spreadsheets per Client’s requirements from Datasets Extract the data from Oracle Clinical and create SAS data sets. Involved in Data Model Preparation, which included drawing of flowcharts, indicating the input data sets, sorting and merging techniques and writing SAS code accordingly. Develop programs producing PK/IK CDISC and specialized datasets, tables, listings, and graphics output for early and late development oncology programs. Designed, created, and validated new studies in Oracle Clinical. Also, reviewed study documentation, translation of study design parameters into Oracle Clinical data objects. Conducted and generated the Regression, Correlation studies and Analysis of Variance (ANOVA) statistical reports. Created various graphs such as Bar Charts, Line Plots, Profiles Chart, Scatter plots using SAS/GRAPH Good experience in working with various procedures like PROC SORT, PROC MEANS, PROC FREQ, PROC TEST, PROC GPLOT,PROC GCHART and PROC MIXED. Created and maintained SAS programs to generate derived datasets and required summary reports for other teams to build ADaM models. Quality Control of tables, listings and graphs by double programming or random verification of values. Created Kaplan- Meier Survival plots using PROC LIFETEST and PROC GPLOT. Performed adequate testing of new databases in Clinical Data Management Systems. Generated various documents (Transport files, Data definition Documents etc.) required for the FDA submission. Created reports in PDF, HTML, XML, RTF using ODS statements and proc template. Worked with Macro’s for generating Tables and Listings. Worked closely with clients to review and finalize the Safety and Efficacy Reports. Produced Ad hoc reports of various kind, Listings, Tables, and Figures (TLGs/TLFs) using Proc report, proc tabulate, data _null_ technique, proc Gplot etc.
Provide SAS Programming and analysis support for phase I and phase II clinical trials. Checked for terms to be in compliance with MedDRA, WHODRUG Dictionaries. Created a SAS customized reports using proc report, proc summary, proc means, proc freq, proc sort and proc transpose. Created various graphs such as Bar Charts, Line Plots, Profiles Chart, Scatter plots using SAS/GRAPH Developed numerous ad-hoc SAS programs to create summaries and listings. Created and maintained SAS programs to generate derived variables and required summary reports, created analysis datasets for ADaM Models. Exposed to use of WebSDM, Janus for validation of data being submitted to regulatory authorities. Developed standard macros and also used existing macros wherever possible Perform adequate testing of new databases in Clinical Data Management Systems. Generated various documents (Define.xml, Transport files, Data definition Documents etc.) required for the FDA submission.
Confidential,East Brunswick, NJ
SAS Developer Nov2009- Mar 2011
Confidential,San Diego, CA Oct2007-Sept2009
Responsibilities: Extracted data from excel, and prepared raw SAS datasets by using SQL pass-through and Proc Import. Created new datasets from raw data files and modified existing datasets using Set, Merge, Sort, Update, and conditional statements. Performed Edit Checks for cleaning up the data in data management. Worked with presentation and reporting procedures like FORMAT, REPORT, PRINT, SORT, etc. Conducted and generated the Regression, Correlation studies and Analysis of Variance using PROC REG, PROC CORR, PROC ANOVA. Developed SAS Ad-hoc programs and Edit-Check Programs for Clinical and Data Management Department Used SAS ODS to produce HTML, PDF and RTF format files. Created SDTM Datasets in compliance to CDISC standards. Designed and created SAS macro based system to perform the SDTM validation checks on the SDTM datasets. Developed Programs using SAS MACROS and SAS Base Procedures. Was involved in validation of tables, listings and datasets using procedures like PROC COMPARE , PROC FREQ,PROC MEANS,PROC FREQ,PROC ANOVA Participated in designing, coding, testing, debugging and documenting SAS Programs and Macros· Used Dynamic Data Exchange (DDE) feature of SAS for importing and exporting of data from and into SAS, MS Access and Excel.
Environment:SAS 8.0, Base SAS, SAS/Macro, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, SAS/ODS, MS Excel.
Confidential, India August 06-July2007 Worked in Phase I & II ofclinicaltrials for studies in the Cardio-Vascular therapeutic area. Integrate Data from wide range of sources including in-houseclinicaldata management systems, labs and contract research organizations and perform data cleaning with data steps using DLM, DSD, and COMMA9. TRUNCOVER, MISSOVER etc. Performed data validation using conditional data steps select-when, if-then statements. Designed statistical tables, graphs, and data listings. Created Data transformation and Data Loading (ETL) scripts for Data Warehouse. Performed Data Analysis on the data sets using PROC ANNOVA, PROC MEAN, PROC UNIVARIATE, PROC FREQ and PROC TRANSPOSE. Generated output files in text format, HTML & PDF format usingSASODS.
Bachelor of Pharmacy