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Sr Statistical Programmer - Full Time

  • South San Francisco, CA
  • March 05, 2020
About The Company
Biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases.
Position Summary
The Senior Statistical Programmer is responsible for developing, evaluating, and modifying computer programs to analyze and evaluate clinical data. This role assists with maintaining the workflow for generating study-specific and ad-hoc clinical data listings, summary tables, and figures.
  • Acts as a liaison between statistical programming, data management, clinical operation, subcommittees and project teams as needed
      Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results
    • Acts independently to determine methods and procedures on new assignments
    • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data
    • Generates CDISC SDTM and ADaM files; SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources
    • Generates safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
    • Reviews Data Management Plan, Data validation plan and edit check specifications
    • Interacts with Statisticians and other clinical team members, perform ad hoc analysis and generate outputs according to the requirements
    • Recognizes inconsistencies and initiates resolution of data problems
    • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles
    • Develops SAS coding and table templates for preparing, processing and analyzing clinical data
    • Suggests tools to improve programming efficiency or quality
    • Establishes monitoring of data transfers for ongoing trials to identify study conduct or data quality issues
    • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection
    • 6-8 years Pharmaceutical/Biotech programming experience
    • Degree in Statistics or other related discipline required
    • Solid knowledge of SAS Programming language required
    • Strong SAS programming and management background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat required
    • Experience in the analysis of complex clinical trial data
    • Ability to use professional concepts to achieve objectives in creative and effective ways
    • Experience working with NDA submission experience is highly desirable
    • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports


    8 (Yrs)

    Required Skill Set

    SAS Macros SDTM ADaM CDISC NDA Submission


    $ 140,000 - 150,000 per Year

    Job Type

    Full Time



    Referral Amount

    $ 2000

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