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    Director, Biostatistics

    Genmab
    8+ years
    $170,625.00---$284,375.00
    Copenhagen Plainsboro
    12 Aug. 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Director of Biostatistics

    Location: Copenhagen, Denmark or Princeton, NJ, USA (Hybrid)

    Company Overview:

    At Genmab, we are dedicated to creating extraordinary futures through the development of cutting-edge antibody therapies that transform cancer treatment and address serious diseases. Our approach is rooted in science and innovation, driven by a team that is caring, candid, and impact-focused. We value being unique, determined, and authentic in our mission to change lives and advance healthcare.

    Role Summary:

    The Director of Biostatistics will serve as a statistical expert within our clinical development team, leading efforts for both early and late-stage programs. This role involves providing statistical expertise and contributing to the strategic planning and execution of clinical trials, as well as engaging with regulatory authorities and ensuring consistency across trials.

    Key Responsibilities:

    Compound/Indication Level:

    • Serve as the lead statistician for designated compounds or indications.
    • Stay abreast of advancements in biostatistics and suggest new methodologies to enhance innovation and efficiency.
    • Engage with regulatory authorities on compound or indication-related discussions.
    • Ensure statistical consistency and data handling across trials.
    • Collaborate with biostatisticians and vendors, ensuring integration of data specifications and transparent communication.

    Clinical Development Team (CDT):

    • Provide statistical input and scientific advice for trial design, analysis, and advanced methodologies.
    • Represent Genmab at regulatory and Key Opinion Leader meetings.
    • Develop and communicate integrated database strategies and analyses to support development decisions and regulatory submissions.
    • Support the creation of presentations, posters, and scientific publications.

    Trial Level:

    • Represent Genmab at conferences, courses, and networking events.
    • Engage with regulatory authorities on trial-specific matters.
    • Coordinate data transfers and ensure high-quality statistical work, including documentation and compliance with Genmab SOPs and ICH-GCP.
    • Oversee vendor activities and contribute to trial result meetings and clinical trial reports.

    Collaboration with Global Drug Safety:

    • Participate in defining and reviewing data packages for Data Monitoring Committees.
    • Approve amendments and updates of data packages and support regulatory submission activities.

    Qualifications:

    • Master’s or PhD in a statistical discipline with at least 12 years of relevant experience.
    • Expertise in statistical analysis, modeling, simulation, and adaptive trial designs.
    • Experience with drug development in biologics, targeted therapies, and companion diagnostics.
    • Knowledge of FDA, EMA, and ICH guidelines, and experience with regulatory submissions, including BLAs.
    • Familiarity with SDTM, ADaM, eSUB, and CDISC requirements.
    • Proven ability to manage complex projects and lead teams.

    Personal Attributes:

    • Passionate about transforming lives through innovative cancer treatments.
    • Committed to scientific rigor and collaborative problem-solving.
    • Flexible, innovative, and determined to excel in a dynamic environment.
    • Enjoys working hard and has a sense of fun in the process.

    About Genmab:

    Genmab is an international biotechnology leader, dedicated to improving patient lives through innovative antibody therapeutics. With over 20 years of experience, we’ve developed a proprietary pipeline featuring bispecific T-cell engagers, immune checkpoint modulators, and antibody-drug conjugates. Our vision for 2030 is to revolutionize cancer and serious disease treatment with our Knock-Your-Socks-Off (KYSO™) antibody medicines.

    Diversity and Inclusion:

    We are committed to fostering a diverse and inclusive workplace. We do not discriminate based on race, color, religion, sex, national origin, age, disability, or genetic information. Learn more about our diversity and inclusion initiatives on our website.

    Application Process:

    To apply, please visit our website and review our privacy policy regarding data handling during the application process. For positions in the Netherlands, we initially offer fixed-term contracts, with potential for renewal based on performance and business conditions.

    Genmab Headquarters:

    • Copenhagen, Denmark
    • Utrecht, Netherlands
    • Princeton, NJ, USA
    • Tokyo, Japan

    Join us at Genmab and be part of our mission to create a better future for patients worldwide.

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