The Statistical Manager 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 Statistical Manager will function as project statistician for the assigned clinical trials, represent Clinical Biostatistics in a multidisciplinary trial team responsible for the execution of the trial (including supervision of biometrical activities performed by CROs), and be accountable for assigned biostatistics deliverables within the responsible areas. Hence, the Statistical Manager should have advanced data analytic expertise based on a foundation 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 when working on projects with good 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
- Participate in-house and/or outsourced biostatistical activities
- Perform trial statistician responsibilities, 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.
- Apply innovative statistical approaches to study design, analysis and data exploration methodologies
- Participate and track study level activities, especially biometrics-related ones; ensure development timelines and objectives are met.
- May represent the company as a statistical subject matter expert in regulatory interactions and other external meetings
- Contribute to clinical development plans
- Arrange/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
- PhD in a statistical discipline
- In-depth understanding of statistical issues in oncology drug development
- At least 2 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.