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    Director, Biostatistics - Princeton, NJ, United States - Genmab

    Genmab
    Genmab Princeton, NJ, United States

    1 week ago

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    Description

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.

    From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.


    The Role:

    The Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below.

    The Director contributes to clinical development strategies and plans. This opportunity will be reporting to the Vice President, Biostatistics.


    Responsibilities:
    Compound/Indication Level
    Act as lead and main point of contact related to Statistics for designated compound/indication
    Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
    Engage with regulatory authoritieson compound/indication level discussions
    Acts as a role model
    Ensures consistency of statistical methods and data handling across trials
    Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
    Supports compound responsible programmer in developing an integrated database specification


    CDT member:
    Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
    Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
    Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
    Drive design and synopsis development together with relevant stakeholders
    Ensure transparent communication to relevant stakeholders from the CDT
    Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
    Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles Trial Level
    Represent Genmab during meetings/congresses and courses and perform professional networking
    Engage with regulatory authoritieson trial level discussions
    Arranges/attends lessons learned to share learnings
    Represents Genmab during Key Opinion Leaders meetings
    Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
    Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
    Ensures state of the art statistical work which includes but is not limited to:
    Applying adequate methods for which a solid scientific foundation exists
    Ensure proper documentation of work done
    Keep oversight and QC essential documents/data provided by vendors
    Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP


    CTT member:
    Participate and represent Biostatistics
    Review and provide input to protocol and amendment development
    Perform vendor oversight according to applicable SOPs

    Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.

    Review assay validation reports, as applicable
    Perform exploratory analysis, ad hoc analyses, and modelling of data
    Review and approve randomization and stratification plans
    Perform UAT of Randomization part of the IRT system as applicable
    Ensure procedures for blinding are in place as applicable
    Support timely delivery of statistical deliverables
    Responsible for planning and conducting trial result meetings
    Review and approve the CSR
    Attend trial and investigator meetings if/as needed
    Collaboration with

    Genmab Global Drug Safety:
    Participate in definition, review, and approval of data packages for Data Monitoring Committees
    Review and approve any amendments, corrections, and updates of data packages

    CRO selection and collaboration:
    Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks
    Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
    Attend operational and steering committee meetings, as applicable
    Support regulatory submission/filing activities Requirements:
    Master's or PhD in a statistical disciplinewith 12 years of experience in relevant technical area
    Experience in statistical analysis, modelling and simulation and adaptive trial designs
    Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
    Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
    Experience with the relevant regulatory requirements for biostatistics processes and SOPs
    Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
    Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
    Experience directing multiple complex projects/studies in a technical... Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity #J-18808-Ljbffr
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