Senior Biostatistician Director

2 days ago

Princeton Junction, New Jersey, United States Genmab Full time
About the Role

At Genmab, we are committed to building extraordinary futures together by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our team is passionate, innovative, and collaborative, and we strive to improve the lives of patients through innovative and differentiated antibody therapeutics.

Key Responsibilities
  • Act as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below.
  • Contribute to clinical development strategies and plans.
  • Engage with regulatory authorities on compound/indication level discussions.
  • Ensure consistency of statistical methods and data handling across trials.
  • Support compound responsible programmer in developing an integrated database specification.
  • Represent the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable.
  • Drive design and synopsis development together with relevant stakeholders.
  • Ensure transparent communication to relevant stakeholders from the CDT.
  • Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles.
Requirements
  • Master's or PhD in a statistical discipline with 12 years of experience in relevant technical area.
  • Experience in statistical analysis, modelling and simulation and adaptive trial designs.
  • Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred.
  • Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics.
  • Experience with the relevant regulatory requirements for biostatistics processes and SOPs.
  • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies.
  • Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions.
  • Experience directing multiple complex projects/studies in a technical capacity.
  • Experience leading and mentoring teams.
  • Proven performance in earlier role/comparable role.
About Genmab

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. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

What We Offer

Genmab offers a dynamic and collaborative work environment, with opportunities for professional growth and development. We are committed to fostering workplace diversity and believe it is essential for our continued success. We are an equal opportunities employer and welcome applications from all qualified candidates.

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