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Sr. Sas Resume

Wilmington, DL

Summary

  • 8+ years of SAS programming experience in Clinical trials (Phase1-III).
  • Good knowledge indifferent phases (phase I to III) of the Clinical Trials.
  • Worked with Senior Statisticians, Medical Writers and Project Managers to provide SAS programming in analyzing the data,generated reports, tables, listings and graphs.
  • Extensive experience in creatingAnalysis datasets, Tables, Listings and graphs.
  • CreatedSDTMdatasets (version 3.1.1) for Lab, AE, DM etc from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.
  • Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS-SQL, SAS ODS, SAS/GRAPH in Windows and UNIX environments
  • Involved in the process of generatingISS/ISEreports for FDA submissions.
  • Hands on Experience in creatingSDTM and ADAMdatasets by followingCDISC standards.
  • Good Experience inStatistical AnalysisusingSAS/STATProcedures such asPROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, PROC GLM, PROC MIXEDetc.
  • Experience withData Validation,designingEdit check programsandparallel development of tables & listingsfor project level programs.
  • Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
  • Strong leadership ability to create, maintain and define strategies to improve the efficiency of running a clinical trial work effectively in a quality-focused environment.
  • Very good experience onCDISC, SDTM and ADAMstandards.
  • Good Experience inClinical Trials, Clinical Data Analysis, Generating Statistical Analysis Files, Tables, Documentation.
  • Thorough knowledge of Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data and Efficacy related data.
  • Good knowledge in creating datasets and table programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA.

Technical Skills

OPERATING SYSTEMS

DOS, Windows 98/2000/XP,UNIX

DATABASES

MS Access, SQL, Oracle

LANGUAGES

SAS, C, C++, SQL,PL/SQL

SAS TOOLS

SAS/Base, SAS/Stat, SAS/Graph, SAS/Access, SAS/Macro, SAS/Connect, SAS/SQL

Professional Experience

Sr. SAS Programmer
Confidential, Wilmington, DelawareJune 2010–Till date

Responsibilities:

  • Involved in QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
  • Worked as aLead programmerfor Phase II studies.
  • Involved in theData mappingfromExisting Raw datatoCDISC SDTMStandard,data mapping fromSDTM to ADAMdomains and review CRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in protocol.
  • To ensure allottedCRFannotation is done and corresponding PeerQCis done withQCcomments documented on tracking tool for each work request.
  • To ensure the completeQCprocess and to develop & validate all clinical programs and are saved intoUNIXrespective to Project folders.
  • Involved in validating andQCof the efficacy and safety tables.
  • Created SAS programs for generating data listings for data review meetings.
  • Involved in PK analysis likeedit checks, PK tablesandPKlistings.
  • Debugged and validated programs for logical/ syntax errors and applied formats and labels for compliance with CDISC guidelines.
  • ProducedTLG’sforIntegrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS).
  • Generated output files inRTF, & PDFformat usingSAS ODS.

Sr. SAS Programmer
Confidential, KansasDec 2008– June 2010

Responsibilities:

  • Analyzedphase IIandphaseIIIclinical trial data of the therapeutic areas-Oncology.
  • Generatedtables,listingsandgraphsas per the mock shells.
  • Createdspecificationsfor developing SDTM datasets and Analysis datasets.
  • Mapping and integrating study data to aCDISC-compliant proprietary analysis data system(SDTM 3.1.2).
  • Table Programming for Integrated Summary of Efficacy(ISE)andSafety (ISS).
  • Created Analysis data sets, Tables, Listings forISSandISE.
  • Successfully engineered a streamlined end-to-end solution forCDSIC SDTMmapping from client’s raw data.
  • PerformedLevel Iand LevelIIQuality Control ofSDTMdatasets and analysis datasets (ADAM) in accordance with the company specifications.
  • Experience in working with Data management team to resolve variousdata issuesby providing edit check programs.
  • ProducedTLG’sfromIntegrated Summary of Safety (ISS) datasets.
  • Usedmacrosextensively and created few to ease the process of coding and to standardize programs.
  • Provided statistical analysis of clinical trial data throughSAS/STATto the statisticians.
  • Attended meetings with clinical research team along with statistician and project manager.

SAS Programmer
Confidential Genetics, WAJuly 2006 – Dec 2008

Responsibilities:

  • Create datasets according toCDISC SDTM
  • Responsible for providingSAS programming and analysis supportforphase IIIclinical study.
  • Created and maintained production programs for tables and listings for final submission to FDA.
  • Created and maintained various validation programs for tables and listings.
  • Used SAS Base ProceduresPROC FREQ, PROC TABULATEandPROC MEANSto validate current results with expected results.
  • Used SAS Macros for generating tables and listings.
  • PROC REPORT, PROC TABULATEandDATA_NULL_programming was used to generate the reports.
  • Customized reports usingPROC TABULATE, REPORT, SUMMARYand also provided descriptive statistics usingProc Means, Frequency,and Univariate.
  • SAS GRAPHwas used to generate the graphs.
  • DevelopedTables, Listings and FiguresusingPROC REPORT.
  • Worked as aLead programmerfor Phase II study.
  • Perform program documentation on all programs, files and variables for future reference.
  • Interacted with statistician and clinical people for creating reports.
  • Experience in providing tables and figures to be incorporated intoClinical Study Reportalong with patient data listings and technical statistical details such as derivations, computations, analyses etc and also involved in discussions with medical writers in the preparation ofClinical Study Report.
  • Involved in validating and QC of the efficacy and safety tables and listings.

SAS Programmer
Confidential Aug 2004 – July 2006

Responsibilities:

  • Involved in Phase II clinical trials
  • Performed statistical analysis usingSAS/Base, SAS Macroand other procedures likeProc freq, Proc Univariate and Proc Means.
  • Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output
  • Preliminary data validation (clinical data quality checks) is done on the clinical trial data usingSAS/SQL
  • Created Safety and Efficacy customized reports for FDA regulatory submissions.
  • Effectively used many SAS functions likeSCAN, SUBSTR, andTRIM.
  • UsedProc Importfor importing data from Excel sheets and CSV files.
  • AppliedPROC SQL,PROC FREQandPROC MEANSfor data analysis and generated report usingPROC TABULATEandPROC REPORT.
  • Performed Ad-hoc Programming and Reporting.
  • Generated Analysis datasets, identified inconsistencies and problems in the database and reported the findings to the appropriate data management department personnel.

Education

Bachelors in pharmacy

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