Director of Biostatistics

2 weeks ago


Plainsboro, New Jersey, United States Genmab Full time
About the Role

We are seeking a highly skilled Director of Biostatistics to join our team at Genmab. As a key member of our clinical development team, you will play a critical role in supporting the development of our innovative antibody products.

Key Responsibilities
  • Act as a statistical expert supporting the clinical development of compounds, including early and late-stage programs.
  • Contribute to clinical development strategies and plans, ensuring consistency of statistical methods and data handling across trials.
  • Engage with regulatory authorities on compound and trial level discussions, representing Genmab at meetings and conferences.
  • Lead and mentor teams, driving design and synopsis development, and ensuring transparent communication to relevant stakeholders.
  • Represent Genmab at regulatory meetings, Key Opinion Leaders meetings, and network meetings, as applicable.
  • Support the development and communication of scientific input to presentations, posters, and articles.
  • Coordinate data transfers from/to business partners, ensuring state-of-the-art statistical work and proper documentation of work done.
Requirements
  • Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical area.
  • Experience in statistical analysis, modeling, and simulation, as well as adaptive trial designs.
  • Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics.
  • Experience with regulatory submissions, including BLAs, and previous experience in dealing with Health authorities.
  • Experience directing multiple complex projects/studies in a technical capacity.
  • Proven performance in earlier role/comparable role.
About Genmab

Genmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. We are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.

We are a fast-growing, dynamic company that thrives on connecting with each other to innovate. 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 are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.



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