Senior Biostatistician Director

4 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
Job Description

At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.

The Director of Biostatistics and Data Science 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.

Key Responsibilities:

  • 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 authorities on 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 collaborators
    • Ensure clear communication to relevant partners 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
  • 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 team members 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 field with 8+ (AD) and 12+ years (Director) 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 in advising multiple complex projects/studies in a technical capacity
  • Experience leading and mentoring teams – (Director)
  • Confirmed performance in earlier role/comparable role

About Genmab

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.

We thrive on connecting with each other to innovate and transform the lives of patients through innovative cancer treatment.

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