…will function as the lead statistician for the assigned clinical projects…
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
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
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.
At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.
Founded in 1999, the company is the creator of four approved antibodies. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies and intends to leverage these technologies to create opportunities for full or co-ownership of future products.
Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
In case you have any questions, please feel free to reach out to Beirholm Search, Hanne Beirholm tel. 29440080.