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Søborg

    Biostatistics Outsourcing Specialist - Søborg, Danmark - Novo Nordisk A/S

    Novo Nordisk A/S
    Novo Nordisk A/S Søborg, Danmark

    for 4 dage siden

    Novo Nordisk A/S background
    Beskrivelse

    Do you have experience in working with clinical trial programming and a firm knowledge of clinical drug development? And do you have a strategic mindset and strong communication skills as well as an interest in working with suppliers within Biostatistics?

    You might be the one we are looking for to be part of driving the outsourcing of Biostatistics deliverables in clinical studies. Apply today and join us for a life-changing career

    The Position
    Novo Nordisk is looking for a highly motivated professional to join our Biostatistical oversight team as a Biostatistical Outsourcing Specialist. As a member of our team, you will play a critical role in coordinating our efforts in ensuring the quality, accuracy, and integrity of our outsourced clinical trial data. Working closely with our vendors and the therapy projects to ensure that all regulatory and Biostatistical requirements are met.

    In this role, you will be responsible for setting a direction for how the clinical oversight of the biostatistical deliverables will be performed, developing innovative approaches, tools, and presentations of the trials data across many outsourced trials, ensure that appropriate oversight is maintained throughout the trial conduct. You will collaborate closely with our data science teams and other stakeholders to ensure that all vendor data deliverables meet Novo standards and are conducted in an efficient, effective, and ethical manner.

    Your responsibility will also be to collaborate closely with internal stakeholders to define project requirements, timelines, and deliverables. Together with the Biostatistics oversight team, ensure compliance with regulatory requirements, internal quality processes, and industry standards.

    You will be responsible for identifying and mitigating risks associated with outsourcing biostatistical services and provide regular updates to Biostatistics management on vendor performance and projects status.

    Qualifications
    We realise that few people are experts at everything. But if you can nod your head at some of the following attributes then you could be the person, we are looking for:

  • M.Sc., PhD. degree in Natural or Technical Sciences (or equivalent theoretical background – please qualify in application)
  • 5 years of experience within clinical development within biostatistics, ideally with a focus on clinical trial outsourcing
  • Expert programmer within SAS, R and/or Python
  • Strong knowledge of regulatory requirements related to the conduct of clinical trials and data deliverables.
  • Excellent communication and collaboration skills, with the ability to work closely with vendors, data science team members, and other stakeholders
  • Strong problem-solving and critical thinking skills, with the ability to drive decision making and identify areas for improvement

    • About the department
    In the Novo Nordisk Development function, we are responsible for managing clinical drug development worldwide, ensuring that our processes follow global standards, regulations and business ethics while still delivering viable and innovative medicine.

    We are a strategic function to the Data Science organisation. We provide strategic support and part of driving cross functional strategic initiatives. The team consist of engaged self-driven experts with a diversity of scientific backgrounds, such as data science and statistics, programming and in-depth knowledge across Biostatistics and Data Management processes, innovation, automation, digitalization tools and strategy development.

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