The Associate Director of Biostatistics supports the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence for Clinical Research & Development and Medical Affairs programs with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents the Clinical Biostatistics function for cross-functional and intra-departmental teams or working groups.
Specifically, the Associate Director will function as the lead statistician for the assigned clinical projects such as a compound in clinical development or an indication in a large clinical development program, represent Clinical Biostatistics in a multidisciplinary clinical team responsible for the execution of clinical trials (including supervision of biometrical activities performed by CROs), and be accountable for all biostatistics deliverables within the responsible areas. As such, the Associate Director should have comprehensive data analytic expertise based on deep understanding of statistical principles and a strong track record of applied experience leading to successful program support, is effective in the use of relevant computational tools for study, experiment, or trial research objectives, and applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.
• Develops and maintains advanced competences in statistical analysis, modelling and simulation and advanced trial designs
• Ensure that clinical trials meet scientific, regulatory, and quality requirements
• Perform management of in-house and/or outsourced biostatistical activities
• Perform trial statistician responsibilities as needed, including attendance of clinical team meetings, authoring Statistical Analysis Plans, reviewing Case Report Forms, designing of clinical trials of all phases (including clinical pharmacology studies), review of protocols/amendments, conducting statistical analyses, and performing just-in-time analyses, etc.
• Contribute to the development of clinical development plans
• Apply innovative statistical approaches to study design, analysis and data exploration methodologies
• Plan and track compound or indication-level activities, including resources; ensure development timelines and objectives are met
• Represent the company as a statistical subject matter expert in regulatory interactions and other external meetings
• Arranges/attends lessons learned to share learnings
• Represents Genmab during external meetings/congresses
• Acts as a role model
• Proactively engages in department activities
• Leads various initiatives within the department
• Proactively contributes to support a global organization
• Acts as mentor for new employees or consultants
• PhD in a statistical discipline
• In-depth understanding of statistical issues in oncology drug development
• At least 5 years of industry experience in statistical analysis within a clinically related subject
• Experience with oncology clinical trials
• Proficient programming skills in statistical softwares, such as SAS and R.
• 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