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Sr. Sas Programmer/analyst Resume

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Deerfield, IL

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PROFESSIONAL SUMMARY:

  • 6+ years of experience as a SAS programmer/Analyst in Clinical/Healthcare industries
  • Strong experience in producing SDTM and ADAM domains in accordance with CDISC
  • standards.
  • Good knowledge of new drug & device release process from IND submission to getting
  • approved from FDA.
  • Strong experience in Phases I – III of clinical trials including edit checks, protocol
  • violations, safety reviews and patient profiles.
  • Worked with statisticians to analyze clinical trial data, generate tables, listings and graphs.
  • Strong experience in various SAS procedures like Contents, Print, Freq, Means, Univariate,
  • Summary, Report, Plot, Format, Transpose and SQL in generating reports.
  • Good knowledge of various SAS modules like SAS/BASE, SAS/STAT, SAS/SQL,
  • SAS/GRAPH, SAS/ACCESS, SAS/MACROS and SAS/ODS.
  • Strong working experience in modifying existing SAS programs and creating new SAS
  • programs using MACROS, including application for data cleaning.
  • Experience in producing ISD/ISS for FDA submissions.
  • Knowledge of 21CFR Part 11 and ICH guidelines.
  • Strong inter personal communication skills.
  • Ability to work independently as well as in a group.

TECHNICAL SKILLS:

Operating Systems: UNIX, Windows NT/98/2000/XP
Languages : SQL, PL/SQL, COBOL, VB, C, C++, JAVA, HTML
SAS Software : SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, 
SAS/ACCESSS, SAS/MACROS, SAS/ODS
Application Packages : MS-Excel, MS-Word, MS-Access, MS-Visio, ARENA
RDBMS : Oracle 8i/9i, DB2, Access, EDC

PROFESSIONAL EXPERIENCE:

Sr. SAS Programmer/Analyst Jan ’08 – Present 
Confidential, Deerfield, IL

My Role:

  • Produced SDTM and ADaM specifications in accordance with CDISC standards by mapping
  • the annotated variables from CRF’s to the SDTM standard variables.
  • Helped European Organization in harmonizing SDTM specifications for therapeutic specific
  • studies.
  • Produced SDTM and ADaM domains in accordance with CDISC standards from raw
  • datasets.
  • Assisted Statistician’s and company CDISC standard’s team in determining type of SDTM
  • domain for therapeutic specific datasets.
  • Made lab specifications for data transfer from central labs.
  • Experience in working with extension protocol studies. Generated new datasets by setting
  • together primary and extension datasets.
  • Imported data from STC files to SAS datasets using Proc Cimport.
  • Produced and validated TLF’s according to SAP and table shell templates using standard
  • macros.
  • Reviewed the raw data listings for QA and QC before locking the database.
  • Generated PDF files for clinical trial reports and for submissions to FDA.
  • Worked on generating interim analyses reports for submitting Abstracts as per statistician
  • guidelines and requests.
  • Generated ad-hoc reports in RTF/XLS files using ODS as per the medical writer’s needs.
  • Produced patient profiles for medical writing.

Environment: UNIX, SAS/BASE, SAS/ODS, SAS/GRAPH, SAS/ACCESS, SAS/MACROS, 
EDC, MS-Access and MS-Excel.

SAS Programmer/Analyst Nov ’05 – Dec ’07 
Confidential, Deerfield, IL

My Role:

  • Generated Tables, Graphs and Listings for phase II & III of clinical trials according to SAP.
  • Produced SDTM and ADaM domains in accordance with CDISC standards from raw
  • Datasets using SDTM/ADaM specifications.
  • Worked with Statisticians and Clinicians to identify critical variables for the edit checks
  • and QA.
  • Assisted data management in designing the annotated CRF’s for phase II & III of
  • clinical trials.
  • Imported data from Excel/CSV files to SAS datasets using Infile and Input statements.
  • Created and validated Derived/Analysis datasets according to derived data requirements
  • (DDR) and SAP from raw datasets using sorting, concatenating and merging techniques.
  • Generated line graphs and bar graphs using SAS/GRAPH.
  • Produced ISD/ISS for submissions to FDA.
  • Created reports in HTML/PDF/RTF files in style format using ODS.
  • Produced define.pdf files using Metadata for submissions to FDA.
  • Generated SAS Transport files for regulatory submissions.

Environment: UNIX, SAS/BASE, SAS/ODS, SAS/GRAPH, SAS/ACCESS, SAS/MACROS, 
METADATA, DB2, MS-Access and MS-Excel.

SAS Programmer Aug ’03 – Sept ‘05
Confidential

My Role:

  •  Generated SAS datasets by reading raw data using input statements.
  • Manipulated data using Merging, Appending, Concatenating and Sorting techniques.
  • Imported data from Excel/CSV files to SAS datasets using Infile and Input statements.
  • Performed descriptive statistics using various SAS procedures like PROC MEANS,
  • PROC UNIVARIATE, PROC FREQ and PROC SUMMARY.
  • Experience in data cleaning and validation.
  • Generated reports using PROC PRINT and PROC REPORT.
  • Created reports in HTML/PDF/RTF files in style format using ODS.
  • Used SAS/GRAPH to present data analysis using PROC GPLOT.
  • Created SQL queries to perform segmentations as required by the team.

Environment: PC-SAS, SAS/BASE, SQL, MS-Access and MS-Excel.

EDUCATION: 
Computer Sciences

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