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Director, Biostatistics and Data Science

4 weeks ago

Princeton Junction, New Jersey, United States Genmab Full time
About the Role

At Genmab, we're committed to building a future where innovative cancer treatments transform the lives of patients. As a Director of Biostatistics and Data Science, you'll play a critical role in driving our mission forward.

Key Responsibilities
  • Lead statistical expertise in clinical development, supporting compound and indication leads for 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 indication level discussions, representing Genmab at meetings and conferences.
  • Collaborate with cross-functional teams to develop and implement statistical analysis plans, ensuring timely delivery of statistical deliverables.
  • Participate in the development of integrated databases, ensuring state-of-the-art statistical work and adherence to Genmab SOPs and ICH-GCP.
Requirements
  • Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical areas.
  • Experience in statistical analysis, modeling, and simulation, as well as adaptive trial designs.
  • Proven performance in earlier roles, with a strong track record of leading and mentoring teams.
  • Experience working with FDA, EMA, and ICH guidance for drug development, as well as regulatory submissions and data packages.
About Genmab

Genmab is an international biotechnology company with a core purpose of improving the lives of patients through innovative and differentiated antibody therapeutics. Our team is passionate, innovative, and collaborative, with a commitment to diversity, equity, and inclusion.