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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.

The Role:

The 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 Director contributes to clinical development strategies and plans. This opportunity will be reporting to the Vice President, 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 authoritieson 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 authoritieson 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 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
CRO selection and collaboration:
Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks
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)
Attend operational and steering committee meetings, as applicable
Support regulatory submission/filing activities


Requirements:
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 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...

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