Senior Manager, Biostatistics

Over de vacature

Overview

As Senior Manager, Biostatistics, you will lead statistical support for designated compounds and indications, guiding trial design, analyses, and regulatory interactions. You'll collaborate across CDT, CTT, and vendor teams to ensure consistent methods and transparent data handling. You'll contribute to strategy, integrated analyses, and scientific communication, shaping development decisions through advanced statistics. This role sits at the heart of Genmab's mission to deliver impactful antibody medicines and drive oncology innovation.

Arbeidsvoorwaarden / Benefits

• 401(k) with 100% match up to 6%
• Comprehensive health benefits (medical, dental, vision)
• Voluntary insurance plans (critical illness, accident)
• Paid vacation, sick leave, holidays, parental leave
• Backup care and family support resources
• Tuition reimbursement and lifestyle spending account

Verantwoordelijkheden

• Act as lead statistician and main statistics contact for designated compound/indication
• Advise on innovative biostatistical methodologies to improve efficiency
• Engage with regulatory authorities on compound/indication level discussions
• Ensure consistency of statistical methods and data handling across trials
• Facilitate information sharing among biostatisticians and vendors
• Support integrated database specifications and planning for integrated analyses
• Provide statistical input to CDT strategy and synopsis development
• Represent the CDT/company at regulatory, KOL, and partner meetings
• Oversee protocol design and amendments, analysis plans, and results communication
• Coordinate data transfers with partners, programmer, and data manager
• Review eCRF setup, validation plans, and trial randomization/DSUR
• Support timely delivery of statistical deliverables and trial result meetings
• Review CSR and support regulatory submission activities

Belangrijkste vereisten

• MS / PhD or equivalent in statistics

• 5+ years in relevant area (preferred)

• Experience in statistical analysis, modelling, simulation, and adaptive trial designs

• Experience with clinical trials, oncology preferred

• Proficient in SAS or equivalent statistics software

• Excellent oral and written communication

• Ability to work independently and in teams

• Proactive, quick learner, and able to thrive in fast-paced environments

• Goal-oriented and able to contribute to Genmab's success

• oral and written communication

• independence and teamwork

• proactivity

• statistical analysis

• modelling and simulation

• adaptive trial designs

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