Director Biostatistics

Responsibilities

• 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
• Supports compound responsible programmer in developing an integrated database specification
• Provides scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
• Represents the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
• Drives design and synopsis development together with relevant stakeholders
• Ensures transparent communication to relevant stakeholders from the CDT
• Ensures availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
• Supports development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles
• Represents 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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