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Senior Statistical Programmer Resume

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WA

SUMMARY

  • 7 years of experience in SAS programming for various pharmaceutical and CRO’s.
  • Extensive experience in integrating data from various studies for ISS and ISE.
  • Skilled in developing SAS programs on UNIX as well as Windows environment.
  • Very good knowledge and work experience about the CDISC standards (SDTM and ADaM).
  • Used Open CDISC to check if the CDISC data is compliant.
  • Annotated CRF according to CDISC SDTM standards.
  • Experience in reviewing ADaM specifications.
  • Good knowledge of controlled terminology and medical dictionaries like MedDRA and WHO Drug.
  • Experience in altering existing SAS programs using macros in order to improve ease, speed and as well as consistency for results.
  • Experienced in creating, validating and executing various tables, listings and graphs to assist theStatisticians.
  • Extensive knowledge in writing SAS Macros and using stored and compiled macros.
  • Experience in Ad Hoc Programming.
  • Experience in generating E - Submission (NDA) deliverables.
  • Developed Define.xml and Define.pdf files for FDA submissions.
  • Experience in handling / working on multiple projects and studies.

TECHNICAL SKILLS:

Statistical Analysis Using: SAS (SAS STAT, SQL, MACROS, PROC S, and GRAPH)

Database/Software: UNIX, ORACLE, MS OFFICE

PROFESSIONAL EXPERIENCE:

Confidential, WA

Senior Statistical Programmer

Responsibilities:

  • Worked on Phase III/IV and ISS studies.
  • Implemented CDISC Standards for Analysis Data following ADaM Implementation guide.
  • Created specifications for ADSL, ADAE, ADEX, ADCM, ADLB and ADTTE analysis datasets based on ADaM TA standards.
  • Developed analysis datasets, tables, listings and graphs.
  • Performed verification of SAS-generated outputs (table, listings and graphs) via Independent programming.
  • Discussed with statisticians about choosing appropriate statistical models and giving appropriate explanations on statistical results.
  • Established and maintained libraries of fully documented and validated SAS Programs/macros/procedures, which are used and recycled.
  • Ensured proper and consistent implementation and maintenance of guidelines and standards within the department.
  • Ensured the proper and timely delivery of Ad Hoc reports as required.
  • Developed MACROS to facilitate producing similar tables.
  • Pooled safety data from multiple studies for ISS.
  • Generated various listings like summary profiles and patient profiles for CSR.
  • Produced RTF and HTML formatted files using SAS/ODS for presentation and further analysis.
  • Imported Data from Excel, CSV, Tab, DLM and flat files into SAS using various Importing techniques.
  • Responsible for the proper coding and documentation of SAS programs to ensure quality according to SOPs.
  • Supported E Submission deliverables.
  • Reviewed Define.xml and Define.pdf files for FDA submission.
  • Organized off shore operations and monitored development efforts to deliver the product with quality.
  • Oversaw the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverables are created per agreed timelines and to high quality standards.

Confidential, DE

Sr Statistical Programmer

Responsibilities:

  • Implemented CDISC Standards for both Study data as well as Analysis Data following SDTM and ADaM Implementation guides.
  • Developed safety analysis datasets and summary reports like tables and listings.
  • Performed verification of SAS-generated outputs (table, listings and graphs) via Independent programming.
  • Organized libraries of fully documented and validated SAS programs/macros/procedures, which are used and recycled.
  • Ensured proper and consistent implementation and maintenance of guidelines and standards within the department.
  • Provided SAS Programming using SAS/Base, SAS/Macros and SAS/Reports.
  • Ensured the validation and quality assurance of the output.
  • Ensured the proper and timely delivery of Ad Hoc reports as required.
  • Knowledge of CRF-Annotation with respect to various database designs.
  • Used SAS/ODS for generating different output formats as requested.
  • Responsible for the proper coding and documentation of SAS programs according to SOPs.

Confidential, NJ

SAS programmer

Responsibilities:

  • Created and Validated analysis datasets, tables, listings and ad hoc reports.
  • Created macros for Interpolation and Area Under Curve.
  • Generated various listings like summary profiles and patient profiles for CSR.
  • Converted Raw data to SDTM compliant.
  • Actively participated and fixed several issues and suggested new output formats to meet the statistician’s requirements.
  • Reviewed the protocols, statistical analysis plan and assisted the medical writing team in submitting the clinical study reports for the FDA.
  • Involved in creating e-submission deliverables as per CTD Guidelines.
  • Created programs from scratch and maintained existing programs.
  • Used Macro libraries routinely in many SAS programs.
  • Imported and exported data from other data sources such as Excel, Access.
  • Performed data validation, quality review of programs coded by other programmers.

Confidential

SAS programmer

Responsibilities:

  • Created the designated Tables, Figures, and Listings according to the Statistical Analysis Plan (SAP) and following the directive of the Programming Manager.
  • Performed verification of SAS-generated outputs (tables, listings and graphs) via independent programming.
  • Reviewed mock-up tables, listings, analysis datasets specifications and provided feedback to statistician.
  • Integrated data from multiple studies for ISS and ISE.
  • Implemented CDISC SDTM Standards.
  • Involved in creating transport files for electronic submissions to FDA.
  • Performed Ad Hoc programming as per client’s requests.

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