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Senior Biostatistics Director

2 months ago


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

We are seeking a highly skilled and experienced Senior Biostatistics Director to join our team at Genmab. As a key member of our Biostatistics department, you will play a critical role in supporting the clinical development of our compounds and indications.

Key Responsibilities
  • Act as a statistical expert and lead on designated compound/indication, providing scientific and technical guidance to support innovation and improve efficiencies.
  • Engage with regulatory authorities on compound/indication level discussions, ensuring consistency of statistical methods and data handling across trials.
  • Collaborate with cross-functional teams to develop and implement clinical development strategies and plans.
  • Represent Genmab at regulatory meetings, conferences, and courses, performing professional networking and ensuring clear communication to relevant partners.
  • Ensure the availability of integrated databases and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs.
  • Support the development and communication of scientific input to presentations, posters, and articles.
Requirements
  • Master's or PhD in a statistical field with 8+ 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 working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions.
About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We are committed to fostering workplace diversity and believe it is essential for our continued success.