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    Director Project - London, United Kingdom - Emmes

    Emmes
    Emmes London, United Kingdom

    3 weeks ago

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    Description
    Head of Biopharma Biostatistics - Remote
    UK Remote

    The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation.

    We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

    If you share our motivations and passion in research, come join us You will be joining a collaborative culture that empowers every Emmes employee - from entry level through top executive - to contribute to our clients' success by sharing ideas openly and honestly.

    The Head of Biopharma Biostatistics serves as a member of Emmes' biopharma leadership team ensuring high-quality, on time, and on budget statistical deliverables and supporting business development activities for potential biopharma opportunities.

    Designs clinical development plans, clinical trial protocols, and statistical analysis plans in collaboration with our biopharma partners.

    Leads and oversees statistical deliverables including but not limited to execution of statistical analyses, interim safety and efficacy reports, clinical study reports, and scientific manuscript development.

    Fosters collaborative relationship with Sponsors and Emmes project team members serving as a point of contact for project statistical deliverables,
    Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings)
    Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g.

    Responsible for successful delivery of biostatistics and statistical programming services to Emmes' biopharma clients overseeing budget, timelines, and quality of biostatistics related deliverables.

    Serves as an escalation point for biostatistics related client, quality or budget concerns for biopharma projects, resolving concerns or appropriately escalating to global biostatistics and biopharma leadership.

    Leads statistical only or limited scope projects including managing budgets, timelines, deliverables, and change orders
    Provides input into professional development and technical training standards for the global biostatistics department
    Effectively supervises biostatistics and statistical programming staff providing mentorship, feedback and conducting performance reviews
    Promotes staff participation and achieves a high degree of engagement across the global biostatistics department with a focus on staff supporting biopharma projects
    Proactively identifies high-performing staff and provides them with mentorship and opportunities for career growth
    MS or PhD in Biostatistics, Statistics, or Epidemiology
    Typically has 12+years' experience with a PhD or 15+ years experience with a MS degree in a biostatistics environment
    Demonstrated leadership and project management experience.
    Follow us on Twitter - @EmmesCRO
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