SUMMARY

• SAS Programmer with 7 Years of experience in using SAS for programming and reporting in Pharmaceutical industry.
• Strong experience in Base SAS, SAS/MACROS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/CDI and SAS/SQL in Windows.
• Experience in transforming data in various formats (excel, CSV, ASCII) into SAS datasets.
• Developed programs in SAS Base for converting the Oracle Data into SAS datasets using SQL Pass through facility and library engines.
• Excellent command in producing reports employing various SAS procedures like Proc Report, Proc Tabulate, Proc Mean, ProcFreq, ProcUnivariate, Proc Transpose, and Data NULL etc.
• Strong experience using SAS/GRAPH to produce Graphs by employing SAS procedures such as Proc GPLOT and Proc GCHART.
• Exceptional ability in problem solving, data analysis, complex reports generation with macro and data transfer between different environments.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM).
• Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.
• Excellent communication, interpersonal skills with strong analytical and problem solving skills. Ability to learn quickly and take up new tasks and responsibilities. Can work effectively in cross - functional team environments.
• Good team player with excellent technical and interpersonal skills. Pro-active, self-motivated and able to work independently as well as in team.
• Experienced in producing RTF, PDF, and MS Excel formatted files using SAS ODS facility.
• Created SAS data sets and generated listings, Analysis Data Sets(ADS), graphs and tables (TLG) as per Statistical Analysis Plan (SAP), also performed validation of the CDISC Models.
• Experience in data cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
• 100% Project completion on time while meeting strict timelines and budget requirements.

TECHNICAL SKILLS

SAS Skills: BASE SAS, SAS/Enterprise Guide, SAS/DI 4.3SAS/MACRO, SAS/CONNECT, SAS-SQL, SAS/STAT, SAS/GRAPH, SAS - ODS, SAS/ACCESS, SAS/CDI.

SAS Procedures: TRANSPOSE, CONTENTS, MEANS, CHART, PLOT, TABULATE, UNIVARIATE, SUMMARY, SORT, SQL, FORMAT, FREQAND DATASETS

Operating Systems: MS WINDOWS2003/2008

Databases: ORACLE

PROFESSIONAL EXPERIENCE

Confidential

Clinical SAS Programmer

Responsibilities:

• Loading the data from various sources into the system.
• Worked with statisticians in analyzing the Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP) and departmental guidelines.
• Created reports for online and batch applications for various servers.
• Modified data using SAS/BASE and Macros.
• Understanding and using departmental utilities, processes, and procedures where applicable.
• Involved in publications, programming and testing of utility macros for standard reports and validation.
• Involved in analysis of Phase II and III clinical trials.
• Created SDTM datasets and ADAM datasets according to CDISC standards.
• Prepared graphs using the modified data for business analysis.
• Produced Safety reports in PDF format.
• Worked with Data management team, investigating data issues and solving technical problems.
• Accuracy, completeness, quality, and timeliness of clinical programming deliverables.
• Performed QC of derived datasets, TLG’s and coded programs and involved in Data Validation.
• Performed program documentation on all programs, files and variables for future .
• Programmed all study-specific edit checks and review listings.

Environment: SAS 9.2 SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ACCESS, MS Excel/Word/PowerPoint

Confidential, RTP, NC

Clinical SAS Programmer

Responsibilities:

• Created, derived and pooled datasets, listings and summary tables.
• Verified the accuracy and integrity of data by performing validation checks written in SAS and investigate data related errors, outliers, and missing values.
• Developed and executed edit check programs according to specifications provided by data management operations for purposes of database verification.
• Involved in managing phase II and III clinical trial data in the respective projects.
• Used SAS SQL Pass through facility and Libname facility to import and create datasets from Oracle database.
• Developed and executed Proc SQL queries for merging, concatenating, and updating large volumes of data.
• Used Base SAS (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc.) and SAS/STAT procedures (REG, GLM, ANOVA, UNIVARIATE etc.) for summarization, Cross-Tabulations and statistical analysis purposes.
• Created complex and reusable Macros for various instances for automating listings and graphing of data for analysis.
• Developed statistical reports by using Proc Report, Data null and SAS Macro.
• Executed report programs and imported the results into Excel for data analysis.
• Created Adhoc reports using the SAS procedures and created reports using ODS statements and Proc Template to generate different output formats like pdf and excel.
• Created SDTM datasets according to CDISC standards using Base SAS and validated using validator tools.
• Collaborated with Data Management to annotate raw data with standardized variables and formats using Proc Datasets, Proc Formats.
• Performed data extraction from various repositories and pre-process data when applicable.

Environment: SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/MACRO, SAS/GRAPH, SAS/STAT, Windows.

Confidential, Nashville, TN

Clinical SAS programmer

Responsibilities:

• Involved in managing randomized phase II and III clinical trials data.
• Extracted data from Oracle using SQL Pass through facility and generated ad-hoc reports.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs.
• Developed new or modified SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, Functions and conditional statements.
• Extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Generated Tables and Listings for inclusion in Clinical study reports and regulatory submission.
• Participated in preparing study results as well as ISS,IND and NDA application for FDA submissions using SAS.
• Modified macros for report generation using SAS Macros as per the Biostatistician’s requirements.
• Developed safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, and Clinical Research Managers as appropriate.
• Gone through the documentation like study protocols, SAP's, CSR etc.,
• Supervision of Clinical data base building.
• Generated derived data sets for the statistical analysis as per SAP.
• Generated Ad-hoc reports and browser viewable reports using SAS\ODS.
• Successfully handled multi-projects/tasks at a time.
• Got a good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.

Environment: SASBASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, ORACLE CLINICAL

Confidential, Ann Arbor Michigan

Clinical SAS programmer Junior

Responsibilities:

• Successfully implemented statistical reporting processes for regular data collection and clinical data analysis.
• Analyzed Phase II and III Clinical Trials.
• Experience with SAS programming and in data step and with various SAS procedures in Base SAS and SAS/Stat.
• Performed Data analysis, generated reports, listings and figures using SAS TOOLS - SAS/BASE, SAS/MACROS, SAS/SQL, SAS/CONNECT, SAS/ACCESS.
• Retrieved ORACLE tables with PROC SQL using PASSTHRU facility.
• Used sorting and merging techniques along with SAS functions on the input data sets for Data manipulation, to get the required output and then writing the code using SAS tools.
• Created SAS customized reports using the DATA NULL technique for evaluations.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY.
• Also produced descriptive statistics using PROC MEANS, FREQUENCY AND UNIVARIATE.
• Used the SAS Macro facility to produce weekly and monthly reports.

Environment: SASBASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ACCESS

Confidential

SAS Programmer

Responsibilities:

• Analyzing the task before doing the configuration.
• Maintaining large data sets, i.e. reading in data from various sources in various formats to create SAS data sets and/or ASCII files.
• Documenting the process, i.e. documenting all the possible information about the application like SAS programs, DATA files and source.
• Creating ad-hoc reports.
• Identifying the tools to use in the process.
• Implementing the process in intervals and testing the process.
• Used SAS ODS to create HTML, RTF and PDF outputs files in the process of producing reports.
• Used SASPROC SQL Pass through Facility to work with oracle database.
• Used SAS DATA NULL and PUT statements to create the customized reports.
• Extensively using existing macros for report generation using SAS/Macros as per the customer’s requirements.
• Default Report output is HTML and provided the options of RTF& EXCEL formats using SAS/ODS statements.
• Used FTP to download SAS Formatted Data into EXCEL AND CSV format.

Environment: SAS /Base, SAS/Macro, SAS/CONNECT, SAS/STAT, SAS/GRAPH.