Biostatistics Professional Lead for Clinical Development

4 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

Role Overview

As a Biostatistics Professional Lead, you will play a key role in supporting the design, execution, analysis, interpretation, and reporting of clinical trials for our innovative cancer treatments. You will collaborate with cross-functional teams to ensure the statistical aspects of our business-critical and regulatory commitments are met.

This position requires a strong foundation in statistical principles and applied experience leading to successful program support. You will apply high-quality statistical methodology when working on projects and demonstrate a good understanding of the disease/scientific/functional area and health authority acceptability.

Main Responsibilities

  • Compound/Indication Level
  • Act as lead and main point of contact related to Statistics for designated compound/indication.
  • Follow scientific and technical progress within the field of biostatistics in drug development and advise on new methodologies that may support innovation and improve efficiencies.
  • Engage with regulatory authorities on compound/indication level discussions.
  • Audit and optimize existing processes to ensure consistency of statistical methods and data handling across trials.
  • Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor.
  • Support the development of an integrated database specification.
  • Trial Level
  • Represent Genmab during meetings/congresses and courses, and perform professional networking.
  • Engage with regulatory authorities on trial level discussions.
  • Coordinate lessons learned sessions to share best practices.
  • Represent Genmab during Key Opinion Leaders meetings.
  • 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

  • MS / PhD or equivalent in a statistical discipline with 2+ - 5+ years of experience in relevant technical areas.
  • Experience in statistical analysis, modeling, and simulation, as well as adaptive trial designs.
  • Experience in working with clinical trials, preferably in oncology.
  • Proficient programming skills in statistical software's, such as SAS.
  • Excellent oral and written communication skills.
  • Ability to work independently as well as in teams.
  • Confident, self-reliant, and a quick learner.
  • Proactive and open-minded.
  • Ability to prioritize and work in a fast-paced and changing environment.
  • Results-oriented and committed to contributing to the overall success of Genmab.

The estimated salary range for this position is $120,000-$160,000 per year, depending on qualifications and location.

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