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Biostatistical Programmer

Interfuse Staffing

Biostatistical Programmer

National
Full Time
Paid
  • Responsibilities

    The Biostatistical Programmer will work collaboratively with team members to develop workflows and SOPs that are aligned with industry standards as well as conduct the necessary activities to execute a clinical trial.

    ? Program mapped and analysis datasets per CDISC standards, tables, listings, and figures and other programming activities in a timely manner

    ? Perform quality control review of programming activities to ensure that outputs meet quality standards and project requirements

    ? Create and maintain statistical programming project documentation, including: project documentation, testing, and verification/quality control documents and programs

    ? Negotiate and establish accurate time estimates for completion of study programming activities with internal team members and Biostatistical Management

    ? Direct the programming activities of other programming personnel and monitor progress on programming deliverables

    ? Assist in developing programming SOPs/Workflows

    ? Be knowledgeable of industry regulations

    ? Program efficiently and accurately in SAS

    ? Act as resource for SAS programming within organization

    ? Participates in a highly collaborative environment as an integral member of a clinical project team to create data displays and data summaries for studies

    ? Serves as a supporting programmer on multiple projects

    ? Ability to collaborate effectively with non­statisticians and project managers, to work independently with minimal guidance, and as part of a team

    ? Effective oral and written communication and interpersonal skills

     

    Qualifications

    • The right candidate will have CDISC, STDM, and ADaM experience. Also, will have worked for a CRO

    ? Bachelor’s degree in Biology, Biotechnology, Mathematics, Statistics, Computer Science, or a related field plus 2 years of experience as Bio­Statistical/Analysis Programmer or related role

    ? Proficient knowledge of SAS/BASE, SAS/SQL, SAS/STAT, SAS GRAPH, and SAS Macro Language

    ? Programming or producing analysis datasets, summary tables, data listings and graphical representations of clinical trials data at a Pharmaceutical company or Contract Research Organization (CRO);

    ? Using clinical regulatory guidelines (FDA/CFR, ICH/GCP, CDISC) in programming decisions

    ? Statistical programming or reports in Phase I­III clinical trials utilizing SAS Programming (SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL);

    ? Application of CDISC guidelines mapping data to SDTM and ADaM formats required