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Biostatistician Innovation Leader
4 weeks ago
We are seeking a seasoned Biostatistician to join our team at Genmab. As a Director of Biostatistics, you will play a key role in supporting the clinical development of compounds and acting as a statistical expert for both early and late-stage programs.
Responsibilities- Lead and contribute to clinical development strategies and plans, driving innovation and improvement in statistical methodologies and data handling.
- Act as a main point of contact related to Statistics for designated compound/indication, engaging with regulatory authorities and providing scientific advice.
- Ensure consistency of statistical methods and data handling across trials, collaborating with biostatisticians and vendors to share knowledge and best practices.
- Support the development of integrated databases and specifications, ensuring timely delivery of statistical deliverables.
- Represent Genmab during meetings and congresses, performing professional networking and sharing expertise in biostatistics.
- A Master's or PhD in a statistical field with 8+ years of experience in relevant technical area.
- Proven experience in statistical analysis, modeling, simulation, and adaptive trial designs, with a focus on drug development in biologics, targeted therapies, and companion diagnostics.
- Familiarity with FDA, EMA, and ICH guidance for drug development pertaining to statistics, as well as experience working with SDTM, ADaM, eSUB, and CDISC requirements.
- Strong communication and leadership skills, with experience mentoring teams and advising multiple complex projects.
- An estimated salary range of $120,000 - $180,000 per year, depending on location and experience.
- The opportunity to work with a talented team in a fast-growing, dynamic company that values innovation and excellence.
- A collaborative and open environment, with opportunities for growth and professional development.
