Associate Director, Biostatistics

Company Overview
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
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.

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

Ensure proper documentation of work done

Keep oversight and QC essential documents/data provided by vendors

Ensure 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…