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    Senior Statistical Programmer - delhi, India - ACL Digital

    ACL Digital
    Default job background
    Technology / Internet
    Description
    Senior Statistical Programmer (6-8 years of exp)

    Location:
    Remote


    ROLES and RESPONSIBILITIES:
    Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
    Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safetyand efficacy
    Develop and/or validate Tables, Listings,and Figures using SAP and mock shells
    Create or review P21 reports, define ) and Reviewersguide (RGs) for CDISC Data Standards
    Ability to work independently and as part of a team environment
    Provide the status of assignedtasks to the Study Lead Programmer
    Actively participating in the study meetings and support as backup lead
    Identify, communicate, and manage study-based risks and issues within the timeframe
    Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
    Contribute to the development of Statistical Programming standards and processesto improve the quality, productivity, and efficiency
    Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
    Provide guidance, mentoring, and training for junior team members as appropriate


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