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Director of Biostatistics

2 months 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 innovative antibody products and therapies.

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 the highest level of scientific rigor and excellence.
  • Lead and collaborate with cross-functional teams to design and implement statistical methodologies and data handling procedures.
  • Engage with regulatory authorities on compound and trial level discussions, ensuring compliance with relevant regulations and guidelines.
  • Represent Genmab at regulatory meetings, conferences, and other events, promoting our innovative approaches and therapies.
Requirements
  • Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical areas.
  • Proven track record of leading complex projects and teams, with a strong focus on statistical analysis, modeling, and simulation.
  • Experience working with FDA, EMA, and ICH guidance for drug development, as well as regulatory submissions and approvals.
  • Strong leadership and mentoring skills, with the ability to inspire and motivate teams to achieve excellence.
About Genmab

Genmab is a global biotechnology company dedicated to transforming the lives of patients through innovative antibody therapeutics. Our team is passionate about pushing the boundaries of science and medicine, and we are committed to fostering a culture of excellence, collaboration, and innovation.

We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and talented individual who shares our passion for innovation and excellence, we encourage you to apply for this exciting opportunity.