Senior Biostatistics Lead — Clinical Trial Strategy

Genmab; København; On-site; DKK 1,100,000 - 1,500,000; Full time

Job summary

Genmab in Denmark seeks a Senior Manager, Biostatistics to lead statistical activities for designated compounds and indications, up to proof of concept and trial responsibility.

You will shape trial design, analyses, and integrated data strategies, collaborate with CDT, trial teams, and regulators, and ensure robust statistical methods across studies. This role emphasizes leadership and scientific excellence.

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 authoritieson 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
• 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
• Represent Genmab during meetings/congresses and courses and perform professional networking
• Engage with regulatory authoritieson 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
• 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

Job description

Genmab in Denmark seeks a Senior Manager, Biostatistics to lead statistical activities for designated compounds and indications, up to proof of concept and trial responsibility.

You will shape trial design, analyses, and integrated data strategies, collaborate with CDT, trial teams, and regulators, and ensure robust statistical methods across studies. This role emphasizes leadership and scientific excellence.