Senior Biostatistics Director

3 weeks ago

Princeton, New Jersey, United States Genmab Full time

About the Role

At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.

We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Associate Director acts 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.

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
  • Ensure consistency of statistical methods and data handling across trials
  • Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
  • Support compound responsible programmer in developing an integrated database specification

CDT member:

  • Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
  • Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
  • Drive design and synopsis development together with relevant stakeholders
  • 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

Trial Level:

  • Represent Genmab during meetings/congresses and courses and perform professional networking
  • Engage with regulatory authorities on trial level discussions
  • Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
  • Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
  • Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP

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 and targeted therapies preferred
  • 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
  • Proven performance in earlier role/comparable role

About You

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment

You are a generous collaborator who can work in teams with diverse backgrounds

You are determined to do and be your best and take pride in enabling the best work of others on the team

You are not afraid to grapple with the unknown and be innovative

Genmab

Genmab is an international biotechnology company with a core purpose guiding its team to strive towards improving the lives of patients through innovative antibody therapeutics

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company

No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex, national origin, age, disability, or genetic information

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