Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
The Biostatistician may act as lead and main point of contact related to statistics and statistical programming on one or more projects/development programs and acts in accordance with Genmab SOPs and ICH GCP.
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 aim for the next level in your career and have the inquisitiveness, the interest, the drive and the power to pursue it?
Here we can offer you a highly innovative biotech company with a rich pipeline and at the forefront of cancer therapy development. It is a small organization with a short chain of command. You will be part of teams where ideas are both welcomed and challenged.
This is a newly established position in Copenhagen and you will be reporting to the Senior Director,Biometrics.The Biostatistician will work closely with the Clinical Management Team. The key responsibilities include but are not limited to:
- Ensure consistency of statistical methods and data handling across trials within a project
- Ensure all project related work and information is shared between biostatisticians and statistical programmers involved in the project and with the programmers (at the vendor)
- Provide statistical input to trial designs, synopses and protocols
- Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
- Ensure development of an integrated database specification
- Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
- Ensure state of the art statistical work which includes but is not limited to:
- Applying adequate methods for which a solid scientific foundation exists
- Proper documentation of work done
- Keep oversight and QC essential documents/data provided by vendors
- Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP
Skills and experience
You will have a minimum of 5 years’ experience as Biostatistician in the pharmaceutical/CRO industry preferably within the oncology therapeutic area.
Besides you must have competence within the following areas:
- Systematic and organized
- Clinical development including ICH-GCP
- Problem solving and decision making
- Good communication skills and ability to communicate scientific matters in a clear and concise manner
- Quality mindset
- Presentation skills
- Process development
- Proactive and accountable
- Analytical and able to interpret and present clinical data and other complex information
Besides all the personal and educational requirements, we need a person with a strong mindset. A person, who wants to learn fast and to gain influence. You must be adaptable for changing needs, changed plans and capable of handling a series of parallel tasks and discussions.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful applicant a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
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. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Beirholm Search, Hanne Beirholm tel. 29 44 00 80