Associate Director, Biostatistics

About Genmab

At Genmab, we are dedicated to building extra[not]ordinary® 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, champion and maintain 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. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Role Overview

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

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.
• Ensures 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; ensuring trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP.

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 trial and investigator meetings if/as needed.
• Collaboration with Genmab Global Drug Safety: 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.

Experience & Qualifications

• 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 dealing with Health authorities such as discussions/negotiations in filing strategies.
• Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions.
• Experience directing multiple complex projects/studies in a technical capacity.
• Proven performance in earlier role/comparable role.

Key Skills/Competency

• Biostatistics
• Clinical Trials
• Regulatory Submissions
• Statistical Modeling
• Adaptive Design
• ICH-GCP
• CDISC Standards
• Data Analysis
• Drug Development
• Vendor Oversight