Clinical Trials Biostatistician
1 week ago
Job Summary
We are seeking a highly skilled Clinical Trials Biostatistician to join our team at Genmab. The successful candidate will be responsible for providing statistical expertise to support the clinical development of compounds and will work closely with cross-functional teams to ensure the success of our projects.
Key Responsibilities
- Act as a statistical expert supporting the clinical development of compounds and trials
- Provide statistical input to overall strategy and synopsis development
- Engage with regulatory authorities on compound and trial level discussions
- Represent Genmab at meetings with regulatory authorities, Key Opinion Leaders, and partners
- Support the development and communication of scientific input to presentations, posters, and articles
Requirements
- Master's or PhD in a statistical field with 8+ years of experience in relevant technical area
- Experience in drug development in biologics, targeted therapies, and companion diagnostics
- Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
- Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities
About Genmab
Genmab is a biotechnology company that leverages the effectiveness of an agile working environment to improve employee work-life balance. Our offices are designed as open, community-based spaces that foster collaboration and innovation.
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