As Senior Biostatistician you will work in close collaboration with colleagues from several locations in Europe and the United States. You will be part of a global organization and a work environment characterized by people empowerment, new challenges and devoted and talented colleagues.
Global Clinical Operations is part of the Clinical Development department and is responsible for managing clinical cancer trials from early FIH studies to late stage trials while ensuring that processes lives up to regulations and business ethics.
Are you a competent and experienced biostatistician today? Is your perspective broader than a clinical trial and do you want to challenge drug development? Do you have the inquisitiveness, the interest and the drive to help us make a difference to patients suffering from cancer? Then this job may be yours. You will be part of global project teams where ideas are both welcomed and challenged.
As Senior Biostatistician you will report to Senior Director, Clinical Operations. You will be part of the Clinical Management Team (CMT) responsible from running Clinical trials ranging from FIH trials to phase III trials. The operational work within clinical operations is outsourced to Contract Research Organizations (CROs). You will be involved in the oversight of the CROs various statistical assignments including trial design development, protocol writing, eCRF design, statistical analysis and sections of integrated clinical trial reports and presentations of results to internal and external stakeholders. You may also be an active member of the Core Development Team.
Your main responsibilities will include but are not limited to:
- Provide statistical input into the design of clinical trials applying state of the art statistical designs/methodology needed to meet the overall objective and regulatory requirements
- Prepare input to protocols and statistical analysis plans
- Ascertain that the clinical data are appropriately analyzed and reported
- Provide statistical support for integrated reports and submissions preparation
- Contribute to Clinical Development Plans
- Support preparation of manuscripts
- Work closely with different departments at Genmab
- Interact and co-ordinate activities with CROs and consultants
- Represent the company on statistical matters in meetings with regulatory authorities, key opinion leaders and similar experts / bodies
- Do quality control of statistical deliverables
- Degree in Biostatistics/Statistics or relevant quantitative sciences degree and a Masters or PhD in a statistical subject
- You have a thorough understanding of statistical issues
- At least 3-5 years of experience in statistical analysis in a clinically related subject
- Experience with oncology trials would be an advantage
- You have good SAS programming skills
- Good oral and written English communication skills are mandatory
- You are able to work independently as well as in teams
- You are confident, self-reliant, and a quick learner
- You are a dedicated team player and an inspiring communicator with excellent social skills
- You are proactive, open minded and enjoy leading teams and inspire trust among colleagues
- You have a quality mindset and are able to prioritize your work in a fast paced and changing environment
- You are result- and goal-oriented and committed to contributing to the overall success of Genmab
At Genmab we strive to improve the lives of cancer patients by creating and developing innovative antibody therapeutics. With two marketed products and a robust pipeline of differentiated antibodies, Genmab is working to transform the treatment of cancer.
We are motivated by knowing that our work has the potential to make a real difference for cancer patients and their families. Our culture values innovation, determination, teamwork, and integrity. We work cross-functionally and internationally as one global team, while individuals and local teams have the autonomy to drive the development of innovative products and technologies that could provide next generation cancer treatments. Please refer to our homepage www.genmab.com/careers for more information about working at Genmab.
How to apply
Please mark your application “Senior Biostatistician” and send it to email@example.com. For more information on this vacancy, please contact Hanne Beirholm tel. 29 44 00 80.
Interviews will be conducted on an ongoing basis, so please don’t hesitate to apply.