Sage Therapeutics

  • Statistical Programmer, Consultant (Contract)

    Job Locations US-MA-Cambridge
    Posted Date 1 week ago(10/11/2018 9:40 AM)
    ID
    2018-2282
    # of Openings
    1
    Category
    Clinical
  • Overview

    Responsibilities

    • Provide statistical programming support for clinical trials.
    • Utilize SAS to generate and validate CDISC SDTM, ADaM compliant datasets and TLFs based on SAP.
    • Utilize SAS to generate any ADHOC related analysis for various needs (internal, publications, ect.).
    • Review SDTM/ADaM TLFs for regulatory, CDISC compliance and SAP.
    • Generate/Review specification for SDTM and ADAM mapping.
    • Oversight of CROs to ensure quality and timely deliverables.
    • Collaborate with cross functional teams on ongoing basis representing statistical programming on Study Management Teams.
    • Review Statistical Analysis plan and other related docs.
    • Work independently.
    • Manage multiple projects/tasks, and appropriately prioritize these tasks.

    Qualifications

     

    The successful candidate for this position will have a proven track record of SDTM/ADAM, TLFs programming supporting clinical trial execution and regulatory submissions, and must therefore:

     

    • Bachelor’s degree in statistics, mathematics, computer science, management information systems, or related field of study is required; MS in statistics or biostatistics is desirable.
    • Have at least 7-8 years of experience in the pharmaceutical industry.
    • Have strong technical SAS programming skills (at least 7-8 years) that can be used in producing various types of outputs: datasets, TLFs.
    • Have strong statistical programming skills to produce deliverables either on scheduled or ADHOC basis (tables, listings, figures).
    • Strong knowledge with FDA and CDISC/SDTM requirements for compliant datasets, programs, and validation processes is a must have.
    • Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
    • Heavily involved in designing, developing & validating CDISC SDTM/ADAM specifications and datasets for clinical trials.
    • Experience with producing outputs submitted to the FDA and other regulatory agencies (IND, ISS, ISE, Annual Reports, DSUR, post marketing support, etc.).
    • Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP and 21 CFR Part 11 rules and regulations.
    • Demonstrable abilities to work on most tasks independently (with limited guidance and supervision).
    • Excellent organizational skills: can prioritize multiple tasks and goals to ensure the timely completion.
    • Excellent communication skills with the ability to quickly adapt to a fast-paced environment.
    • Expected to communicate regularly with CRO vendors to ensure quality and on-time delivery and with members of various internal teams (data science, medical science, and program development) to provide delivery-related updates.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Excitement about the vision and mission of Sage.

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