Senior Biostatistics Consultant

4 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking a highly skilled Senior Biostatistics Consultant 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 compounds and indications.

Key Responsibilities:
  • Lead and act as the main point of contact for statistics on designated compound/indication levels.
  • Advise on new methodologies that may support innovation and improve efficiencies in drug development.
  • Engage with regulatory authorities on compound/indication level discussions.
  • Act as a role model and ensure consistency of statistical methods and data handling across trials.
Trial Level Responsibilities:
  • Represent Genmab during meetings/congresses and perform professional networking.
  • Engage with regulatory authorities on trial level discussions.
  • Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations, and clinical trial reports.
  • Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable.
Requirements

To be successful in this role, you will need:

  • A Master's or PhD in a statistical field with 8+ years of experience in relevant technical areas.
  • Experience in statistical analysis, modelling, 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 dealing with Health authorities such as discussions/negotiations in filing strategies.
  • Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions.
About You

You are passionate about transforming the lives of patients through innovative cancer treatment. You bring rigor and excellence to all that you do and are a fierce believer in Genmab's science-driven approach to problem-solving. You are a generous collaborator who can work in teams with diverse backgrounds and are determined to do and be your best.

Estimated Salary Range: $120,000 - $180,000 per year

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