Solution Architect, Treasury
Clearsulting
Senior Manager, Biostatistics
Genmab
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $122,000 - $183,000 per year
Job Level
Senior
About the role
- Act as a biostatistician supporting the clinical development of compounds as compound lead and/or trial responsible statistician
- Act as lead and main point of contact related to Statistics for designated compound/indication
- Follow scientific and technical progress within the field of biostatistics and advise new methodologies
- Engage with regulatory authorities on compound/indication and trial level discussions
- Ensure consistency of statistical methods and data handling across trials
- Provide scientific advice to the CDT including design of trials, analyses and advanced methodologies
- Represent the CDT/the company at regulatory meetings, KOL meetings, and partner meetings
- Drive design and synopsis development and ensure transparent communication to stakeholders
- Ensure availability of integrated databases and planning/conduct of integrated analyses
- Support development and communication of presentations, posters, and articles
- Coordinate data transfers with partners and participate in vendor oversight and CTT activities
- Review and provide input to protocol and amendment development, SAPs, CSRs, and other trial documentation
- Perform exploratory, ad hoc analyses, modelling; review randomization plans and perform UAT of IRT systems
- Support timely delivery of statistical deliverables and regulatory submission/filing activities
Requirements
- MS / PhD or equivalent in a statistical discipline
- 5+ years of experience in relevant area preferred or demonstrated capability
- Experience in statistical analysis, modelling and simulation and adaptive trial designs
- Experience in working with clinical trials
- Preferred experience with oncology clinical trials
- Proficient programming skills in statistical software’s, such as SAS
- 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
