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Senior Biostatistics Director
2 months ago
We are seeking a highly skilled and experienced Senior Biostatistics Director to join our team at Genmab. As a key member of our Biostatistics department, you will play a critical role in supporting the clinical development of our compounds and indications.
Key Responsibilities- Act as a statistical expert and lead the development of statistical strategies and plans for designated compounds and indications.
- Collaborate with cross-functional teams to ensure consistency of statistical methods and data handling across trials.
- Develop and maintain strong relationships with regulatory authorities and provide scientific advice on compound and indication-level discussions.
- Represent Genmab at regulatory meetings, conferences, and courses, and perform professional networking.
- Ensure the availability of integrated databases and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs.
- Support the development and communication of scientific strategies and input to presentations, posters, and articles.
- Master's or PhD in a statistical field with 8+ years of experience in relevant technical areas.
- Experience in statistical analysis, modeling, and simulation, as well as adaptive trial designs.
- 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.
- Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions.
- Experience in advising multiple complex projects/studies in a technical capacity.
- Confirmed performance in earlier role/comparable role.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success.
