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Senior Biostatistics Manager

2 months ago

Plainsboro, New Jersey, United States Genmab Full time
About the Role

The Senior Biostatistics Manager will play a key role in supporting the design, execution, analysis, interpretation, and reporting of clinical trials for Clinical Research & Development and Medical Affairs programs at Genmab. This position will provide statistical expertise to support business-critical and/or regulatory commitments, contribute to program plans, and represent the Clinical Biostatistics function in cross-functional and intra-departmental teams or working groups.

Key Responsibilities
  • Act as a biostatistician supporting the clinical development of compounds, primarily up until proof of concept, and/or as trial responsible statistician with responsibilities including supervision of biometrical activities performed by CROs.
  • Represent Biostatistics in a multidisciplinary trial team responsible for the execution of the trial and be accountable for assigned biostatistics deliverables within the responsible areas.
  • Apply advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support.
  • Use relevant computational tools for study, experiment, or trial research objectives and apply high-quality statistical methodology when working on projects with a good understanding of the disease/scientific/functional area and health authority acceptability.
Requirements
  • Master's or Ph.D. degree in a statistical discipline with years of experience in a relevant technical area.
  • Experience in statistical analysis, modeling, and simulation, and adaptive trial designs.
  • Experience in working with clinical trials.
  • Preferred experience with oncology clinical trials.
  • Proficient programming skills in statistical software, 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.