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    Director, Oncology Biostatistics - Los Angeles, United States - Penfield Search Partners Ltd

    Penfield Search Partners Ltd
    Penfield Search Partners Ltd Los Angeles, United States

    2 days ago

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    Description
    Our client is a leader in developing innovative therapies for a variety of cancers. They are seeking a Director of Oncology Biostatistics to provide scientific and statistical leadership for key molecules.

    A visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance the delivery of crucial medicines to patients.


    In this role you will:
    ·

    Lead the statistical support for one or more clinical development projects
    ·

    Lead/develop statistical strategy for project development and regulatory submissions
    ·

    Direct or provide statistical leadership for design, analysis and reporting for clinical or other scientific research
    ·

    Lead the development of protocols, statistical analysis plans, and statistical programming plan
    ·

    Provide statistical input to compound/drug development and drive alignment with functional management
    ·

    Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies
    ·

    Demonstrate extensive understanding of statistical concepts and methodology
    ·

    Propose novel statistical methodological approaches to design of scientific studies
    ·

    Train and mentor staff on statistical methodology and operations
    ·

    May supervise contract statisticians or junior Statisticians
    ·

    Gain expertise in innovative statistical methods
    ·

    Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff
    ·

    Develop strategy for data presentation and inference
    ·

    Collaborate in publication of scientific research
    ·

    Act as the liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities
    ·

    Build external scientific connections which foster professional development and promote the reputation of the Statistics department
    ·

    Ensure that all applicable regulatory requirements for work processes are met
    ·

    Critically review regulatory submission documents
    ·

    Represent department in discussions with regulatory agencies

    • Please Possess:
    ·

    PhD (with 8+ years of experience) in Statistics or Biostatistics
    ·

    Ability to identify data or analytical issues, and assist with providing solutions by either applying own skills and
    ·

    knowledge or seeking help from others
    ·

    Ability to build strong relationship with peers and cross-functional partners to achieve higher performance
    ·

    Be highly motivated to drive innovation by raising the bar and challenging the status quo
    ·

    Strong leadership skills and experience in managing cross-cultural or oversea teams

    • Ability to interact effectively with Key Stakeholders:• Clinical development experts
    • Statistical programmers
    • Data science experts
    • Global Medical Affairs experts
    • Regulatory experts
    #J-18808-Ljbffr
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