Senior Manager, Biostatistics

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
• Supports compound responsible programmer in developing an integrated database specification
• CDT Member
• Provides statistical input to overall strategy and synopsis development in the CDT
• Drives design and synopsis development together with relevant stakeholders
• Ensures transparent communication to relevant stakeholders from the CDT
• Supports development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles
• Trial Level
• Represents Genmab during meetings/congresses and courses and perform professional networking
• Engages with regulatory authorities on trial level discussions
• Coordinates data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
• CTT Member
• Participates and represents Biostatistics
• Reviews and provides input to protocol and amendment development
• Performs vendor oversight according to applicable SOPs
• Reviews assay validation reports, as applicable
• Performs exploratory analysis, ad hoc analyses, and modelling of data
• Reviews and approves randomization and stratification plans
• Supports timely delivery of statistical deliverables
• Reviews and approves the CSR
• Attends operational and steering committee meetings, as applicable
• Supports regulatory submission/filing activities

Requirements

• 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
• 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