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Clinical Sas Programmer Resume Profile

Bridgewater, NJ

SUMMARY:

  • Certified SAS programmer with 6 years of experience within the pharmaceutical/biotech industry or CRO
  • SAS programming experience in generating Analysis Datasets/SDTM/ADaM
  • Experience in producing and validating Tables, Listings and Graphs TLG's using Base SAS, SAS/Graph, SAS/Macros and SAS/ODS according to Statistical Analysis Plan SAP .
  • Broad Knowledge of Life Sciences and drug development process from protocol through FDA submissions in the clinical trial process Phase I IV
  • Extensive Knowledge of both CDISC SDTM and ADaM models.
  • Experience in both Clinical SAS programmer and Statistical programmer
  • Knowledge of creating Case Report Tabulation CRT's using CDISC standards
  • Experience in Phase I - IV clinical trials and FDA submissions
  • Experience in Producing RTF, HTML and PDF formatted files using SAS/ODS.
  • Knowledge in creating tables and listings programming for ISS Integrated Summary of Safety and ISE Integrated Summary of Efficacy to the FDA.
  • Experience in SAS/BASE, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/STAT, and SAS /ODS in Windows and UNIX environments.
  • Knowledge of MedDRA, WHO-DRUG, CTC Common Toxicity Criteria , FDA regulations 21 CFR part 11 , ICH guidelines and GCP requirements in new drug development and application process
  • Extensive experience on generating Patient narratives and .XML outputs for FDA regulatory submissions
  • Working experience in Data cleaning and edit checks
  • Worked with different clinical trial domains like Demographic, Adverse Events AE , Serious Adverse Events SAE , Disposition, Medical History MH , ECG, Exposure Ex , Concomitant medication CM , Vital Signs VS and Laboratory Data lab data . Etc.
  • Working knowledge of database design/structures.
  • Proficient in extracting data from Oracle Database into SAS data files using SQL Pass-through facility.
  • Ability to work well with others and independently
  • Worked in various therapeutic areas like Oncology, Vaccines, Alzheimer's, Immunology, CNS, and Endocrinology, Ophthalmology and Gastroenterology Etc.
  • Excellent organizational and communicational skills with high self-motivation, team leadership experience.

TECHNICAL SKILLS:

  • SAS : Base/SAS, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/STAT, SAS/SQL
  • Databases: Oracle, SQL Server 2000, MS Access
  • Languages: C, SQL, PL/SQL, HTML, Visual Basic 6.0
  • Operating Systems: Windows 95/98/NT2000/XP, UNIX

PROFESSIONAL EXPERIENCE:

Confidential

Clinical SAS Programmer

  • Worked on generating raw datasets on CDISC SDTM standards and analysis datasets on ADAM Standards
  • Involved in Statistical programming and validation of Analysis Datasets and Tables, Listings, Graphs TLG'S
  • Created SDTM datasets for Patient narratives.
  • Created Patient narratives and generated .XML outputs for FDA regulatory submissions.
  • Assisted in preparation of various study specific documents
  • Assisted programming for ISS Integrated summary of safety tables and listings
  • Involved in Data cleaning and Edit checks

Confidential

Senior Statistical Programmer.

  • Developed Specifications for analysis datasets as per company standards
  • Generated analysis datasets as per Client standards
  • Analyzed clinical trials data and generated Tables, Listings, and Graphs TLG's as per the Statistical Analysis Plan SAP .
  • Performed validation of datasets and Tables, Listings, Graphs TLG's
  • Involved in Documentation
  • Generated Graphs by employing SAS/GRAPH procedures including PROC GPLOT, PROC GCHART and created HTML,RTF,PDF reports using SAS/ODS.
  • Used Macros for generating Analysis Datasets, Tables, Listings and Graphs
  • Used SAS/STAT procedures such as UNIVARIATE, FREQ, MEANS, GLM, ANOVA and LIFETEST

Confidential

SAS Programmer

  • Involved in Creation of Datasets, Tables for ISS and ISE.
  • Involved in Listings and Graphs for phase I to phase IV trials.
  • Extensively involved in the process of validation of Datasets and validation of Tables and Listings
  • Involved in Review of mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
  • Extensively involved in Data cleaning and Edit checks
  • Extensively used SAS/ODS to produce HTML, PDF and RTF format files.
  • Worked with biostatistician for statistical analysis and data managers for data cleaning

Confidential

Clinical SAS Programmer

  • Produced data Listings and Summary tables.
  • Involved in documentation of several studies phase I to phase III trials .
  • Providing statistical support for generating eRPL book marking for FDA submission studies.
  • Extensively involved in Documentation of studies.
  • Reviewed Protocol and Case Report Forms to identify irregular data entry errors of clinical trial data.
  • Created Safety customized reports for FDA regulatory submissions.
  • Effectively used many SAS functions like SCAN, SUBSTR, and TRIM.
  • Used Proc Import for importing data from Excel sheets and CSV files.
  • Preliminary data validation clinical data quality checks is done on the clinical trial data using SAS/SQL
  • Performed Ad-hoc Programming and Reporting.
  • Designed flowcharts indicating the input data sets and the techniques that would be used sorting, merging, etc. to get the desired output
  • Generated and validated patient profiles for the different studies

Confidential

SAS Programmer

  • Involved in Data Cleaning and Edit checks
  • Worked on creating Analysis Datasets
  • Generated Tables, Listings and Figures TLF's
  • Created ad hoc programs to provide information to the project team and/or client, as required.
  • Involved in Validation of Tables and Listings for clinical study reports.
  • Developed and modified different standard safety reports after study initialization and data extractions.

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