Associate Director, BioStatistics

Overview

At Genmab, we are dedicated to building exceptional futures by developing antibody products and breakthrough medicines that change lives and advance cancer treatment and serious diseases. We strive to create a global workplace where individuals’ unique contributions are valued and drive innovative solutions for patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being authentically determined to do our best is essential to fulfilling our purpose. Our work is serious and impactful, but we have big ambitions, care deeply for pursuing them, and have fun along the way.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Associate 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 described below. The Associate Director contributes to clinical development strategies and plans.

• Compound/Indication Level: Act as lead and main point of contact related to Statistics for designated compound/indication
• Compound/Indication Level: Follow scientific and technical progress within biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
• Compound/Indication Level: Engage with regulatory authorities on compound/indication level discussions
• Compound/Indication Level: Acts as a role model
• Compound/Indication Level: Ensure consistency of statistical methods and data handling across trials
• Compound/Indication Level: Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
• Compound/Indication Level: Support compound responsible programmer in developing an integrated database specification
• CDT member:
  Provide statistical input to overall strategy and the synopsis development in the CDT
• CDT member:
  Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
• CDT member:
  Represent the CDT/the company at regulatory meetings, Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
• CDT member:
  Drive design and synopsis development together with relevant stakeholders
• CDT member:
  Ensure transparent communication to relevant stakeholders from the CDT
• CDT member:
  Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
• CDT member:
  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
• Trial Level: Engage with regulatory authorities on trial level discussions
• Trial Level: Arranges/attends lessons learned to share learnings
• Trial Level: Represents Genmab during Key Opinion Leaders meetings
• Trial Level: Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings, presentations and clinical trial reports
• Trial Level: Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
• Trial Level: Ensure state of the art statistical work including applying adequate methods with a solid scientific foundation and proper documentation
• Trial Level: Keep oversight and QC essential documents/data provided by vendors
• Trial Level: Ensure trial related work is performed in accordance with Genmab SOPs/processes and standards and ICH-GCP
• CTT member:
  Participate and represent Biostatistics
• CTT member:
  Review and provide input to protocol and amendment development
• CTT member:
  Perform vendor oversight according to applicable SOPs
• CTT member:
  Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and…