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 Senior Biostatistician acts as lead and main point of contact related to statistics and statistical programming on one or more projects/development programs and act in accordance with Genmab SOPs and ICH GCP.
The Senior Biostatistician may act as project statistician and is responsible for ensuring oversight and consistency cross more trials within one or more development projects.
The Senior Biostatistician acts as biostatistician on clinical trials and will be part of the CMT. As biostatistician on a trial the Senior Biostatistician will be responsible for carrying out trial related activities or overseeing these including planning, analysis, reporting and publication and participate in other trial related activities.
The Senior Biostatistician may provide input to Genmab clinical drug development programs. The Senior Biostatistician may be responsible for reviewing and providing input to the Clinical and Compound Development Plans developed by the CDT on one or more projects and participates in meetings with KOLs and regulatory authorities.
The Senior Biostatistician may represent Clinical Operations in Project Boards, Global Development Teams, Safety Committees and Operational Committee’s/Steering Committee’s with the partners and or vendors.
The Senior Biostatistician will also give input to the department related activities, the overall department strategy and lead/support various initiatives/activities internally within the department or across departments.
The level of this position will reflect the experience and seniority of the candidate. This position will be based in Princeton, NJ.
- Develops and maintains expert competences within statistical analysis, modelling and simulation and advanced trial designs
- Contributes to the profiling of the company, as highly scientific and specialized within the area of oncology
- Represents Genmab during meetings/congresses and courses and perform professional networking
- Follows scientific and technical progress within the field of biostatistics in drug development and provides advice on new methodologies that may support innovation and improve efficiencies
- Engages with regulatory authorities
- Arranges/attends lessons learned to share learnings
- Represents Genmab during KOL meetings
- 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
Skills & Experience
Moreover, you meet the following professional requirements:
- At least MSc in Statistics or similar
- Thorough understanding of statistical issues in drug development
- At least 3-5 years of industry experience in clinical development
- Experience with oncology trials
- SAS programming skills
- Good 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 lead teams and inspire trust among colleagues
- 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
- Submission experience is an advantage
If you are interested in the position, please apply via https://genmab.loop.jobs/job/Genmab-Princeton-New-Jersey/65253681