Professional Summary:

• 8 years of experience as a SAS programmer/analyst in Clinical domain working in different therapeutic areas in trials ranging from Phase I-IV.
• Hands on Experienced in BASE SAS, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/SQL, and SAS/ODS, SAS/ACCESS, SAS/Graph.
• Experience in analyzing and coordinating clinical data, generating detail summary reports and data validation using FDA regulation procedures.
• Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to the Standard Operating Procedures SOPs .
• Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets, preparing data, producing reports, storing and managing data in SAS.
• Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.
• Validating, testing, debugging SAS code to determine quality, completeness, and accuracy per specifications.
• Involved in the process of generating TLG's Tables, Listings and Graphs for Integrated Summaries of Efficacy ISE and Safety ISS for FDA submission.
• Knowledge of industry regulations and standards guided by CDISC, and FDA including regulatory submissions.
• Expert in concatenating, interleaving and merging SAS datasets.
• Extensive experience in SAS/STAT procedures such as Proc Reg, Proc GLM, Proc Freq, Proc Meansand Proc Univariate.
• Worked with statisticians and data managers to provide SAS programming in analyzing clinical trials data and generated reports such as tables listing and figures for various phases of clinical trials regulatory submissions.
• Involved in creating various SAS Reports satisfying the 21CFR-11 Code for Federal Regulations for electronic data submission.
• Proficient in understanding clinical trials study designs, study protocols, statistical analysis plans SAP , case report form CRF/eCRF , annotated case report forms, and company standard operating procedures SOP
• Experience in SDTM mapping from raw datasets.
• Exceptional ability in problem solving, data analysis and complex report generation.
• Extensive experience in Clinical Data Analysis for Phase I IV Protocols and strong experience in CDISC SDTM standards.
• Thorough experience in analysis of Clinical Trial data and in preparation of SAS datasets/views, Tables, Listings, Graphs, Reports and Summaries as per requests of users, according to Protocols and Statistical Analysis Plans.
• Excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels.
• Ability to work effectively with multiple protocols as an individual and also as a part of the team.
• Result oriented, hard working and committed with a quest to learn new technologies and undertake challenging tasks.
• Excellent written and verbal communication skills with good leadership qualities.

Technical Skills:

Professional experience

Confidential

Clinical SAS Programmer

Responsibilities:

• Used PROC REPORT to produce reports for the purpose of validation.
• Worked on all classes of SDTM domains which include- DM, AE, CM, MH, LB, EG, VS, TA, TV, TS, etc.
• Generated custom Excel spreadsheets using ODS. Used different methods to Export and Import from Excel to SAS and SAS to Excel.
• Worked on Libname facility and ODS tag sets.
• Created SAS data sets by extracting data from various sources and prepared them for statistical analysis. Manipulated data sets by using RETAIN, ARRAY, DATA NULL , SAS Functions, etc.
• Involved in creation of Data Definition Tables DDT SAS Export files .xpt for client submission.
• Extensively involved in creating safety and efficacy tables, listings and figures.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Effectively used many SAS functions like SCAN, SUBSTR, TRIM and applied strategic logic on data using INTCK, INTNX, SUM, and PUT, INPUT functions.
• Used Data set options like MERGING, CONCATENATING, STACKING effectively while creating SDTM.
• Generated clinical data summary tables/Listings/graphs and reports using SAS
• Created SAS datasets from Excel, Oracle database using SAS Macros.
• Developed SAS programs to generate analysis datasets and customized reporting of tables, listings and graphs TLGs specified in the Statistical Analysis Plan SAP .
• Exposed to Annotating CRFs according to the requirements and specifications.
• Responsible for data mapping of raw datasets according to CDISC SDTM data standards.
• Performed Data step programming to manipulate data using set, merge and Proc SQL.
• Worked with Bio-Statisticians to provide statistical analysis using various SAS statistical procedures.
• Experienced in validation QC of Programs, Analysis Datasets and TLGs as per SAP.
• Extensively used SAS Base, Macros, SQL and various statistical procedures to write efficient programs while working on multiple projects.
• Created SDTM datasets from raw datasets for clinical trials.
• Retrieved data from ORACLE, EXCEL, ACCESS and ASCII file and generate SAS datasets using SAS Data Steps, PROC IMPORT, SAS/ACCESS, SAS/SQL and SAS ODS.
• Conducted statistical analyses such as generate descriptive statistical summary, analysis of variance, categorical analyses, regression, logistic regression, correlation, survival analyses etc. using PROC MEANS, PROC SUMMARY, PROCUNIVARIATE, PROCFREQ, PROC ANOVA, PROCREG, PROCCORR, and PROCGLM.
• Provided SAS programming expertise in producing ADS, efficacy and safety summary result with tables, listing, graphs, using SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ACCESS, SAS/GRAPHS, SAS/ODS, and optimizing programs by using advanced SAS Programming techniques for development.
• Extensively used SAS procedures such as PRINT, REPORT, TABULATE, FREQ, MEANS, SUMMARY and TRANSPOSE for producing ad-hoc, customized reports and external files.
• Created SAS customized reports using DATA NULL and PUT statements.
• Used SAS/ODS to create HTML, RTF and PDF outputs files in the process for producing reports.
• Develop, modify, validate and implement SAS programming work according to Statistical Analysis Plan.
• Performed diagnostic checks for the fitted model.
• Prepared written documentation of all SAS steps in the data analysis for future references.
• Interpreted of all results, writing reports, prepared presentation to audience.

Environment: SAS/BASE 9.2, SAS/MACRO, SAS/STAT, SAS/ACCESS, SAS/ODS, Oracle, EXCEL

Confidential

Clinical SAS Programmer:

Confidential a leader in the development and commercialization of new pharmaceutical therapies. It is focused primarily on Phase II-IV clinical trials and associated laboratory and analytical activities.

Responsibilities:

• Cooperated with Statisticians and Team lead for Statistical Analysis Plan development, analysis and reports using SAS.
• Extensively used different Base SAS Procedures like Proc Contents, Proc Print, Proc Sort Proc Format, Functions, Arrays, Retain and SUM Statements Dataset options and statements
• Extensively used different SAS/STAT procedures like Proc Means, Proc Summary, etc.
• Experience with SAS Macro Language for counting treatment groups and performing statistical functions like PROCFREQ, PROC UNIVARIATE, Proc Sort, Proc Print, and Proc Report
• Expert in using formats/In-formats.
• Worked extensively on Excel spreadsheets for importing and exporting data from Excel to SAS and SAS to Excel.
• Developed Macro programs to send SAS procedure output to different destinations, such as HTML, RTF, PDF, and Printer
• Used SAS/ GRAPH, Proc Gplot for displaying graphs
• Provided SAS programming and statistical support to Clinical studies.
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Generated Tables, Listings, Views, Plot and Graph for analysis reports using SAS/Base, SAS/Stat, SAS/Macro, and SAS/Sql.
• Designed Sql query to select, create, append, and update database tables and views.
• Involved in data gathering and functional documentation preparation.
• Involved in data quality checking and documentation, Code reviews QC of the data and co-programmers code.
• Created reports in the style format using ODS statements and PROC TEMPLATE.
• Developed SAS macros, which are used to generate, graphs and reports and also performed statistical analyses with output delivery procedures.
• Cross-validated SAS programs written by other SAS programmers as a part of QA.
• Advanced expertise in data manipulations by using SAS data step statements such as, SAS Formats/In-formats, Merge, DATA NULL , Set, Update, Functions and conditional statements, and by applying advanced SAS programming techniques, such as PROC SQL JOIN/ UNION , PROC APPEND, PROC DATASETS, and PROC TRANSPOSE.
• Imported huge data in to SAS library and sorted according to the class of the drug using ORDER BY option.

Environment: Base/Sas, Sas/ Macros, Sas/ SQL, Sas/Access, Oracle, EXCEL.

Confidential

SAS Programmer/Analyst:

Confidential is a fully integrated pharmaceutical company that discovers, develops and markets novel pharmaceutical products targeting the cancer and other disorders.

Responsibilities:

• Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like CSR and Safety.
• Generated Tables, Listings and Figures.
• Worked extensively on CSV and Excel files.
• Responsible for Developing reports for Safety and efficacy as per study requirements.
• Involved in Developing, Debugging, and the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Extensively used Proc SQL to retrieve, update and report on information from SAS data sets and other database products.
• Modification of existing SAS programs and creation of new programs using SAS Macros.
• Built Macros and create macro variables using LET, CALL SYMPUT, and DATA NULL to help generate analysis data sets and create specified structure of TLFs.
• Ability to quickly debug SAS compiling errors, to review SAS code and quickly identify areas of concern.
• Worked with Statisticians and Clinical Data Managers to provide SAS programming in analyzing the Clinical Trials and generating Reports.
• Created analysis datasets based on the guidelines provided in the Data Definition Tables DDT and following the CDISC standard. Used SDTM model 3.1.2 / ADAM for domain creation and CDISC compliant analysis datasets.
• Generated statistical analysis files, tables, listings, and graphs.
• Collaborated with Statisticians, Data Manager, and other SAS programmers to provide analyses and reports with regards to the assigned projects.
• Imported external files like Excel files, text files, and Database files into SAS data sets using INFILE, LIBNAME, PROC IMPORT, and SAS/Connect, etc.
• Used various procedures such as Proc Means, Proc Freq and Proc Univariate to check assumptions and produce initial analyses.
• Worked with different clinical trials data like Demographic, Medical History, Vital signs, Adverse Event AE , Physical examination.
• Created SAS data sets by extracting data from various sources and prepared them for statistical analysis. Manipulated data sets by using RETAIN, ARRAY, DATA NULL , SAS Functions, etc.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Created Summary Reports and Tabular Reports using Proc Report and Proc Tabulate.
• Written custom safety and efficacy reports by directing SAS output to RTF and HTML files using SAS/ODS.
• Ensured analysis data and programming code meet regulatory and company standards FDA and ICH regulations and are consistently structured to permit efficient programming and reporting.

Environment: Base/Sas, Sas/ Macros, Sas/ SQL, Sas/Access, Oracle.

Confidential

SAS Programmer/ Clinical Data Associate:

Confidential is to help people live healthier lives. To achieve this goal, they are focused on building a modern, adaptable, innovative and inclusive system of health care services.

Responsibilities:

• Performed data analysis and statistical analysis using SAS/Base, SAS Macro and other procedures like Proc freq, Proc Univariate and Proc Means.
• Reviewed SOP's and Report Forms to identify irregular data entry errors of health care data. Created safety and efficacy customized reports for FDA regulatory submissions.
• Extracted data from various database sources like Oracle using Proc SQL pass through facility and SAS/ACCESS libname statements.
• Used Dynamic Data Exchange and Proc Import for inputting data from Excel sheets.
• Involved in creating transport files to move files between different environments.
• Effectively and timely contacted Project Manager of the respective studies about the various Data Issues and resolved the queries through meetings.
• Responsible for writing SAS programs using Base SAS and SAS/Macros to create SAS reports.
• Define System Standards and enhanced the existing system source code using SAS/macros.
• Responsible for coding using Base SAS SAS/Macros to extract clean and validate data from oracle database and SQLSVR database.
• Convert MS excel and CSV data files into SAS datasets using SAS BASE IMPORT facility.
• Extract and analyze Oracle and SQLSVR data tables into SAS data files using SAS PROC SQL.
• Wrote reports using SAS Base and Macros on a UNIX platform using SAS Access to pull data from a large Data Warehouse.
• Actively coordinate to develop and maintain SAS codes/programs in a UNIX environment.
• Developed SAS programs using SAS/BASE, SAS/SQL and SAS/MACROS for state projects in accordance with the business requirements.
• Modify or rewrite an entire report using SAS MACRO, SAS/FUNCTIONS, PROC REPORT, etc. according to new business requirements.
• Ensured leadership in the planning and communication of programming requirements, Analysis, testing QC and release of code in to Production for generating multiple reports and tables.
• Involved in development of CRT for Clinical trial analysis and Electronic submissions to FDA in eCTD format.
• Extracted datasets from database using SAS/ACCESS libname statement and other import methods.
• Verified accuracy and integrity of Clinical data by performing validation checks written in SAS and data cleaning by investigating data related errors and missing values.
• Reviewed clinical study protocols, case report forms and statistical analysis plans for clinical trials.
• Worked with various SAS products SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS MACROS to develop required solutions.
• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis.
• Create a highly available SAS grid-computing environment.

Environment: SAS v8, SAS v9, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACROS, EXCEL SAS/SQL, SAS/ACCESS, SAS/ODS, Oracle 9i Windows XP, UNIX.

Confidential

SAS Programmer:

Confidential is a privately held telecommunications company, which specializes in enterprise network, telephony, and call center technology. I was involved in Data cleaning, Data manipulation, Requirement gathering, Generating Reports, Statistical analysis, Data analysis, worked on Companies customer details, Profits, Selling, Resellers, Distributors.

Responsibilities:

• Extensively used procedures like PROC FREQ, PROC MEANS, PROC SORT, PROC PRINT, PROC TABULATE and PROC REPORT.
• Formatted HTML, PDF,CSV and RTF reports, using SAS - output delivery system ODS
• Used data step options like KEEP, DROP, and RENAME as a part of storage efficiencies. Data set options IF, where, missover, truncover etc. were used in reading raw data files.
• Extracted data from database using various SAS/Access methods including Libname statements and the SQL Pass Through facility.
• Used SAS extensively for Match merge, Append data validation, and Data correction and Cleansing.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Created Summary Reports and Tabular Reports using Proc Report and Proc Tabulate.
• Written custom safety and efficacy reports by directing SAS output to RTF and HTML files using SAS/ODS.
• Experience with SAS Macro Language for counting treatment groups and performing statistical functions like PROCFREQ, PROC UNIVARIATE, Proc Sort, Proc Print, and Proc Report
• Expert in using formats/Informats.

Environment: Base SAS, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/MACROS, SAS/ODS, FTP, MS Excel, UNIX, Main frames, Enterprise Miner, Enterprise guide.