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Parsippany

    Clinical SAS programmer - Parsippany, United States - Katalyst Healthcares and Life Sciences

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    Description
    Responsibilities:
    • Generate and validate tables, listings, and figures (TLF) based on statistical analysis plan (SAP)
    • Work with statistician to provide statistical analysis support for publication effort
    • Use major statistical programming language to perform data analysis for various needs
    • Provide statistical analysis support for post approval studies
    • Write specifications and statistical programs to generate analysis datasets and outputs data analysis tasks with minimal supervision
    • Work with statisticians to develop statistical toolbox for advanced data modelling, tabulation, and visualization
    Requirements:
    • At 3+ years' experience in medical device, pharmaceutical, biotech and/or CRO industries
    • Strong SAS programming skill in producing various types of outputs such as TLFs and datasets
    • Extensive statistical programming experience in producing deliverables either on scheduled or adhoc basis
    • 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
    • Attention to detail and able to adapt to a fast-paced environment
    • Ability to work both independently and in a cross-functional team
    • Excellent communication skills
    • Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance
    • Adequate knowledge in clinical trial research methodology, ICH, GCP and regulations
    • Experiences in medical device and cardiovascular disease is desirable, but not required


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