Senior Biostatistician

4 days ago

Copenhagen, Copenhagen, Denmark Genmab Full time

Genmab is a global biotech company dedicated to transforming the lives of patients through innovative cancer treatment. We are seeking an experienced Senior Biostatistician to join our team in clinical development.

About the Role

The Senior Biostatistician will play a key role in supporting the design, execution, analysis, and interpretation of clinical trials. This includes communication of data evidence for Clinical Research & Development and Medical Affairs programs with minimal supervision. The successful candidate will support statistical aspects of business-critical and/or regulatory commitments, provide input to program plans with limited supervision, and represent the Clinical Biostatistics function for cross-functional and intra-departmental teams or working groups.

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 of new methodologies that may support innovation and improve efficiencies
  • Engage with regulatory authorities on compound/indication level discussions
  • Acts as a role model
  • Ensures consistency of statistical methods and data handling across trials
  • Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
  • Supports compound responsible programmer in developing 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
  • Arranges/attends lessons learned to share learnings
  • Represents 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
  • Contribute to clinical development plans
  • Avgange/attend lessons learned to share learnings
  • Represent Genmab during external meetings/congresses
  • Proactively engage in department activities
  • Actively participate various initiatives within the department
  • Proactively contribute to building a global Genmab organization
  • May act as mentor for new employees or consultants

Requirements

  • MS / PhD or equivalent in a statistical discipline with 2+ - 5+ years of experience in relevant technical area
  • Experience in statistical analysis, modelling and simulation and adaptive trial designs
  • Experience in working with clinical trials
  • Preferred experience with oncology clinical trials
  • 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
  • Result and goal-oriented and committed to contributing to the overall success of Genmab

Compensation Package

Our competitive compensation package includes a salary range of $125,000 - $160,000 per year, depending on your qualifications and experience. Additionally, you will be eligible for bonus opportunities and a comprehensive benefits package.

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