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Lower Gwynedd

    Sr. Statistical Programmer - Gwynedd, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Gwynedd, United States

    1 week ago

    Default job background
    Description
    Responsibilities:
    • Utilize SAS to generate and validate tables, listings, and figures (TLF) based on SAP.
    • Use major statistical programming language to perform data analysis for various needs.
    • Provide statistical analysis support for post approval studies.
    • Evaluate and ensure CDISC compliance of study tabulation and analysis data files.
    • Write specifications and statistical programs to generate analysis datasets and outputs.
    • Perform data analysis tasks with minimal supervision.
    • Provide programming support for data management.
    • Develop statistical toolbox for advanced data modelling, tabulation, and visualization.
    • Participate in reviewing and validating data analysis results.
    Requirements:
    • Strong SAS programing skill in producing various types of outputs such as TLFs and datasets with minimum of 3 years of experiences.
    • Extensive statistical programming experience in producing deliverables either on scheduled or ad hoc basis.
    • BS degree in Statistics, Mathematics, Computer Science, or related field, MS in Statistics or Biostatistics is preferred.
    • Experience with producing outputs submitted to the FDA and other regulatory agencies.
    • Excellent organizational skill to prioritize multiple tasks and goals to ensure timely completion.
    • ttention to detail and able to adapt to a fast-paced environment.
    • bility to work both independently and in a cross-functional team.
    • Excellent communication skills
    • Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance
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