SUMMARY

• Over 7 + years of experience working as a SAS Programmer on various platforms in Pharmaceutical and Health Care Industries.
• Excellent Experience in Clinical Trials, Clinical Data Analysis, Generating Statistical Analysis datasets, Tables, Listings, Graphs and Validations.
• Strong skills in working wif SAS v8.2/v9.0 and BASE SAS, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ODS, SAS/ACCESS.
• Extensive programming experience wif PROC SQL, PROC REPORT, PROC ACCESS, PROC GPLOT, PROC SORT, PROC GCHART, PROC FORMAT, PROC TRANSPOSE, PROC PRINT, PROC COMPARE, PROC APPEND, PROC IMPORT/EXPORT.
• Involved in creating various SAS Reports satisfying teh 21CFR - 11 (Code for Federal Regulations) for electronic data submission.
• Hands on experience in implementing CDISC standards SDTM and ADaM.
• Modified existing SAS programs and created new programs using SAS MACROS to improve ease and speed of modifications as well as consistency of results.
• Working noledge and experience of Microsoft Office tools like MS Access, MS word, MS PowerPoint, MS Excel. Also possess good working noledge in Internet based access and database usage.
• Experience in Creating SAS Datasets, Data manipulation, Reports, Tables, Listings and Graphs (TLG).
• Excellent experience in SAS programming using BASE SAS, SAS/ACCESS, SAS/GRAPH, SAS/MACRO, SAS/SQL, SAS/ STAT.
• Created SDTM Data sets for Lab, AE, DM, EX and from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation.
• Developing SAS programs for data cleaning, analysis, and reporting of clinical data, including sophisticated data manipulation and creating customized listings/reports of clinical data.
• Responsible for providing proper validation, including testing and documentation in accordance wif GCP and company standards.
• Worked on internal and external procedures and regulations eg: clinical SOPs, ICH-GCP, internal standards etc.
• Involved in doing Edit checks, Validation of Analysis datasets, Tables & Listings.
• Knowledge of Software Development Life cycle.(SDLC)
• Effective team player wif strong communication and interpersonal skills as well as self-motivated.
• Individual wif Strong Technical and Analytical abilities.

TECHNICAL SKILLS

SAS TOOLS: SAS 6/7/8/9/9.1.3, SAS/BASE, SAS/MACROS, SAS/STATSAS/SQL, SAS/ACCESS, SAS/CONNECT, SAS/ODS.

OPERATING SYSTEMS: WINDOWS 95/98/2000 and UNIX

OFFICE TOOLS: MS Word, MS PowerPoint, MS Excel

PROFESSIONAL EXPERIENCE

Confidential, Groton, CT

Clinical SAS Programmer

Responsibilities:

• Extracted raw Data from various internal and external sources into SAS.
• 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 wif 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.
• Used PROC SORT, SET, UPDATE and MERGE statements for creating, updating and merging various SAS datasets.
• Validated data is processed based on teh business rules. Used SORT, MERGE, SET statements and created final datasets for analysis.
• Provides load balancing for all SAS servers to improve output put and response time of all SAS clients.
• Analyzed Phase II and III Clinical Trials.
• Developed and maintained programs in SAS using SAS tools for Windows and UNIX in a user support environment.
• Extensively used Base SAS (MEANS, FREQ, REPORT) for summarization, cross-tabulations and statistical analysis purposes and SAS/GRAPH procedures like PROC GPLOT and PROC GCHART to generate reports.
• Wrote programs using base SAS and SAS/Macros to extract data from oracle tables.
• Extracted raw data from warehouse and created SAS data sets dat are required for teh project analysis.
• Knowledge of CTMS, drug discovery and development, bioinformatics, ICH-GCP, drug protocol development, clinical trials, CDISC, SDTM, ADaM, clinical data management, CRF Design, EDC and Pharmacovigilance.
• Involved in creating SAS datasets from flat files and EXCEL data as per requirement.
• Developed Edit check programs to clean invalid data from database.
• Generated tables, listings and graphs including patients demography and characteristics, adverse events, laboratory etc.
• Extensively used different SAS procedures such as PROC MEANS, PROC SORT, PROC FREQ, PROC COMPARE, PROC REPORT, PROC SQL, PROC GPLOT and Data NULL step and other statistical procedures.
• Collaborated wif clinical researchers in teh design of clinical trial selection of clinical endpoints, sample size requirements, protocol development, and Research and teh Case Report Form design.
• Participated in writing of clinical trial reports and presenting of teh trial results.

Environment: SAS/BASE, SAS/MACRO, SAS/ACCESS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, MS WINDOWS 2000.

Confidential, Dublin, CA

Clinical SAS Programmer

Responsibilities:

• Extracted clinical trials data from teh clinical data warehouse (Oracle), using SAS/ACCESS and created SAS data sets.
• Reviewed company SOP’s, Case Report Forms and SAP of teh clinical trials.
• Extensively used SAS procedures like means, frequency and other statistical calculations for Data validation.
• Independently programmed most macros, summary tables, listings, and all documentations completed in compliance wif Federal regulations and ICH and GCP Guidelines.
• Involved in writing code using SAS/BASE and SAS/MACROS to extract, clean and validate data from oracle tables.
• Involved in development of CRT for Clinical trial analysis and Electronic submissions to FDA in eCTD format.
• Maintained CDISC SDTM and ADaM standards Extensive experience wif teh SAS programming and in data step and wif various SAS Procedures in Base SAS and SAS/STAT, including thorough noledge of SAS Macro Language.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macros, SAS/Merge and SAS/Graph, SAS/SQL, SAS/Connect, SAS/Access.
• Data extraction from teh Clinical databases and created SAS statistical analysis files for regulatory submission to FDA approval.
• Designed and created SAS datasets from various sources like Excel datasheets, flat files and Oracle, creating reports and files from existing SAS datasets.
• Reviewed and created electronic data and Clinical data for FDA and electronic submissions.
• Created survival graphs in Excel by transposing SAS datasets into Excel spreadsheets.
• Implemented data management principles, such as joining data set, indexing, data aggregation, record selection, sub-setting, multiple records per case, creation and modification of views, accessing multiple databases.
• Involved in teh process of transferring and converting data from one platform to another for teh future use of different phases of clinical trails.
• Created reports using SAS/ODS and extensively used SAS/ARRAYS.
• Developed SAS macros for data cleaning and reporting and to support route processing.
• Assisted system analysts, data analysts, statisticians and medical writers.

Environment: SAS/BASE, SAS/MACRO, SAS/ACCESS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, and MS EXCEL.

Confidential, Lawrence, MA

Clinical SAS Programmer

Responsibilities:

• Generated statistical analysis files, summary tables, listings and graphs using SAS/BASE, SAS/MACROS, SAS/MERGE, SAS/GRAPH and SAS/STAT.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions.
• Developed and customized reports using PROC REPORT, PROC SORT, PROC FREQ and PROC MEANS and DATA NULL .
• Created new datasets from existing data-sets by using concatenation, merging, interleaving and using conditional statements.
• Defining, Manipulation, Controlling and Reporting/Storage (Query Language) of Clinical Data by using PROC SQL.
• Forecasting teh data transformation, ARIMA modeling and forecasting, regression analysis wif autoregressive errors and regression analysis of panel data.
• Generated routine and ad-hoc reports using PROC PRINT, PROC SORT, PROC FREQ and PROC REPORT.
• Generated required Charts, Graphs and reports using PROC REPORT, PROC GPLOT and SAS/GRAPH for graphical analysis.
• Developed and improved teh efficiency of programs through teh use of SAS macros.
• Moved teh datasets and final results between multiple platforms.
• Created an annotated CRF document dat maps CRF data sets to SAS data sets.
• Validation done on all teh data sets and developed testing scripts and Flag teh scripts according to priority using PI manager Tool.
• Used SAS/ODS facility to generate custom reports and thus directing SAS output to RTF, XML and PDF files.
• Reviewing developed SAS code to eliminate any possible errors and improve functionality.

Environment: SAS/BASE, SAS STATS, SAS/BI, SAS/MACROS, SAS/MERGE, SAS Enterprise Guide, SAS/ODS.

Confidential, San Antonio, TX

SAS Clinical Programmer

Responsibilities:

• Validated datasets as required by teh client to find teh missing data and imported to SAS Environment.
• Extracted data from flat files, MS Excel and Oracle Clinical database and created SAS data sets using different SAS procedures and SAS/SQL “Pass through facility”..
• Generated Descriptive reports and analysis, basic listings, summary statistics tables, one-way frequencies tables and graphs, and tabular or graphical distribution analysis.
• Developed validated and documented programs to create TLG’s (Tables, Listings and Graphs) as per Statistical Analysis Plan (SAP) using SAS reporting procedures like PROC REPORT, PROC SORT, Graphic procedures like PROC GPLOT and analysis procedures like PROC MEANS and PROC FREQ.
• Worked wif SAS Scalable performance Data Server to reduce extraction, transformation and loading times, irrespective of data size.
• Provided flexible data storage options to support business intelligence and analytic application requirements using SAS Intelligence Storage according to teh statistician’s requirements to support different Phases in Clinical Trails.
• Developed and used SAS Macros programs to generate reports, tables and listings for clinical and bio-statistical review.
• Generated Ad-Hoc reports for further analysis using SAS tools.
• Used SAS Analytics for Leverage optimization, project scheduling and simulation techniques to identify teh actions dat will produce teh best results.
• Created SAS reports using teh Data Null technique and Proc Report for NDA submission as per FDA regulations and company standards.
• Used PROC COMPARE to conduct quality control checks on files, tables and listing.
• Created transport files for FDA submissions.

Environment: SAS/BASE, SAS/STAT, SAS/Macro, SAS/SQL, SAS/GRAPH, SAS/ACCESS, Excel, SQL, Windows 2000.