Senior Manager, Biostatistics

Role Summary

The Senior Manager, Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of concept, and/or as trial responsible statistician. This role includes acting as the lead and main point of contact related to statistics for designated compounds/indications.

Responsibilities

• Compound/Indication Level
  • 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
  • Acts as a role model
  • Ensures consistency of statistical methods and data handling across trials
  • Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
  • Supports 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
  • 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
• Trial Level
  • Represent Genmab during meetings/congresses and courses and perform professional networking
  • Engage with regulatory authorities on trial level discussions
  • Arranges/attends lessons learned to share learnings
  • Represents Genmab during Key Opinion Leaders meetings
  • 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
• CTT Member
  • Participate and represent Biostatistics
  • Review and provide input to protocol and amendment development
  • Perform vendor oversight according to applicable SOPs
  • Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.
  • Review assay validation reports, as applicable
  • Perform exploratory analysis, ad hoc analyses, and modelling of data
  • Review and approve randomization and stratification plans
  • Perform UAT of Randomization part of the IRT system as applicable
  • Ensure procedures for blinding are in place as applicable
  • Support timely delivery of statistical deliverables
  • Responsible for planning and conducting trial result meetings
  • Review and approve the CSR
  • Attend operational and steering committee meetings, as applicable
  • Support regulatory submission/filing activities

Qualifications

• MS / PhD or equivalent in a statistical discipline
• 5+ years of experience in relevant area preferred or demonstrated capability
• Experience in statistical analysis, modelling and simulation and adaptive trial designs
• Experience in working with clinical trials
• Preferred experience with oncology clinical trials
• Proficient programming skills in statistical software’s, such as SAS
• Excellent oral and written communication skills
• Ability to work independently as well as in teams
• Confident, self-reliant, and a quick learner
• Proactive and open-minded
• Ability to prioritize and work in a fast-paced and changing environment
• Result and goal-oriented and committed to contributing to the overall success of Genmab