Director Project Management - Princeton, NJ, United States - Genmab

Genmab Princeton, NJ, United States

4 weeks ago

Description

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.

From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

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 authoritieson compound/indication level discussions
Ensures consistency of statistical methods and data handling across trials
Supports compound responsible programmer in developing an integrated database specification
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
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
Represent Genmab during meetings/congresses and courses and perform professional networking
Engage with regulatory authoritieson trial level discussions
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
Applying adequate methods for which a solid scientific foundation exists
Keep oversight and QC essential documents/data provided by vendors
Perform exploratory analysis, ad hoc analyses, and modelling of data
Perform UAT of Randomization part of the IRT system as applicable
Responsible for planning and conducting trial result meetings
Participate in definition, review, and approval of data packages for Data Monitoring Committees
Review and approve any amendments, corrections, and updates of data packages
Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
Support regulatory submission/filing activities
Master's or PhD in a statistical disciplinewith 12 years of experience in relevant technical area
Experience in statistical analysis, modelling and simulation and adaptive trial designs
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...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity #J-18808-Ljbffr

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