Incyte Corporation

Summary The Senior Principal Biostatistician is responsible for providing statistical support to drug development programs. Responsibilities Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols. Write statistical analysis plans. Monitor internal and CRO project activities including timelines, deliverables and availability of resources. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures. Interpret study results and provide review of statistical summary reports of study results for accuracy. Assist in writing relevant sections of the clinical study report. Participate and contribute to authoring of Clinical Development Plan. Participate in pre-IND and NDA activities. Participate in the development and enforcement of SOPs and guidelines. Other responsibilities as required....

Within the Engineering department of Incyte's biotechnology production site in Yverdon-les-Bains, the Methods Engineer is responsible for harmonising the compliance processes of the Engineering department and provides essential support to the maintenance activities, in charge of carrying out the management activities of the production equipment and technical installations. Essential Functions of the Job (Key responsibilities) Harmonize the maintenance processes and procedures of the site. Actively support the handling of non-conformities on maintenance activities and change management. Harmonize processes and support the writing of GMP records (Change control, Deviations, Technical investigations, Preventive and corrective actions). Administer the existing CMMS system and keep it up to date (spare parts stock management, maintenance plans, bills of material and maintenance ranges). Support the implementation of a new CMMS software and more specifically set up the...

Summary This is a leadership position in Medical Affairs Europe. This person will actively participate in/lead a broad range of medical affairs activities, including preparation of support to investigator initiated research (IIR) programs, European medical plan and medical review of Medical Affairs and promotional materials. Responsibilities Provide European level support to the Head of European Medical Affairs. Drive strategy and ensure/facilitate coordination among the European countries for the planning and execution of the European medical plan. Budget management of medical activities related to the assigned assets and regular follow-up meetings to respect the milestones Medical lead of the brand team of assigned assets with active participation to regular Brand team meetings, by providing medical presentations and annual medical brand plan. Then support the implementation of European strategy in accordance with the brand plan and other functions (Commercial,...

Summary The Senior Principal Biostatistician is responsible for providing statistical support to drug development programs. Responsibilities Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols. Write statistical analysis plans. Monitor internal and CRO project activities including timelines, deliverables and availability of resources. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures. Interpret study results and provide review of statistical summary reports of study results for accuracy. Assist in writing relevant sections of the clinical study report. Participate and contribute to authoring of Clinical Development Plan. Participate in pre-IND and NDA activities. Participate in the development and enforcement of SOPs and guidelines. Other responsibilities as...

Summary This is a leadership position in Medical Affairs Europe. This person will actively participate in/lead a broad range of medical affairs activities, including preparation of support to investigator initiated research (IIR) programs, European medical plan and medical review of Medical Affairs and promotional materials. Responsibilities Provide European level support to the Head of European Medical Affairs. Drive strategy and ensure/facilitate coordination among the European countries for the planning and execution of the European medical plan. Budget management of medical activities related to the assigned assets and regular follow-up meetings to respect the milestones Medical lead of the brand team of assigned assets with active participation to regular Brand team meetings, by providing medical presentations and annual medical brand plan. Then support the implementation of European strategy in accordance with the brand plan and other functions (Commercial,...

Summary The Senior Principal Biostatistician is responsible for providing statistical support to drug development programs. Responsibilities Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols. Write statistical analysis plans. Monitor internal and CRO project activities including timelines, deliverables and availability of resources. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures. Interpret study results and provide review of statistical summary reports of study results for accuracy. Assist in writing relevant sections of the clinical study report. Participate and contribute to authoring of Clinical Development Plan. Participate in pre-IND and NDA activities. Participate in the development and enforcement of SOPs and guidelines. Other responsibilities as...