Senior Biostatistician and Team Leader

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

Job Details: We are seeking an experienced Director of Biostatistics and Clinical Research to join our team. The successful candidate will have a strong background in biostatistics and clinical research, with a proven track record of success in directing complex clinical trials and biostatistical projects.

Responsibilities:

  • Oversee the development and implementation of clinical trial designs and statistical methodologies
  • Lead statistical analysis and modeling for designated compounds/indications
  • Collaborate with cross-functional teams to ensure timely and efficient clinical trial execution
  • Ensure compliance with regulatory requirements, including ICH-GCP and FDA/EMA guidance
About You:
  • You have a Masters or PhD in a statistical discipline with 12+ years of experience in relevant technical areas
  • You have a proven track record of success in directing complex clinical trials and biostatistical projects
  • You have experience working with regulatory authorities, including FDA and EMA
  • You have strong leadership and communication skills

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