Senior Biostatistics Director

3 weeks ago

Princeton, New Jersey, United States Genmab AS Full time

About the Role

The Associate Director, Biostatistics will lead the development of clinical development strategies and plans, providing statistical expertise to support the clinical development of compounds. This role will act as a statistical expert, supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs.

Key Responsibilities

  • 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 in drug development and advise of new methodologies that may support innovation and improve efficiencies
  • Engage with regulatory authorities on compound/indication level discussions
  • Act as a role model, ensuring consistency of statistical methods and data handling across trials
  • Support compound responsible programmer in developing an integrated database specification
  • Provide scientific advice to the CDT, including design of trials, analyses, and analyses requiring advanced statistical methodologies/techniques
  • Represent the CDT/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
  • Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
  • 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 8+ 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

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.

Our Commitment to Diversity, Equity, and Inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.

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