Associate Director, Biostats

Associate Director, Biostats

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At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science.

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. The Associate Director contributes to clinical development strategies and plans.

• 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
• Act as a role model
• 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
• 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 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
liRepresent Genmab during meetings/congresses and courses and perform professional networking
• Engage with regulatory authorities on trial level discussions
• Arrange/attend 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
• Ensure state of the art statistical work which includes but is not limited to applying adequate methods for which a solid scientific foundation exists, ensuring proper documentation of work done, keeping oversight and QC essential documents/data provided by vendors, and ensuring trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP
• Participate and represent Biostatistics in the CTT Member role
• 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 trial and investigator meetings if/as needed
• Participate in definition, review, and approval of data packages for Data Monitoring Committees
• Review and approve any amendments, corrections, and updates of data packages
• Support regulatory submission/filing activities

• Master's or PhD in a statistical discipline
• 8+ years of experience in relevant area preferred, or demonstrated capability
• Experience in statistical analysis, modelling and simulation and adaptive trial designs
• Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
• Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
• Experience with the relevant regulatory requirements for biostatistics processes and SOPs
• Experience with regulatory submissions including BLAs and previous experience in…