Statistical leader and project manager for all Biostatistics and Statistical Reporting deliverables globally for a clinical development program As part of the Global Project Team (GPT), ensure that clinical development program meets scientific, regulatory, quality and commercialization requirements Perform matrix management of B&SR project team, supervise biostatisticians on the team. Ensure that statistical expertise from Early Clinical Development, Clinical Pharmacology and Modeling & Simulation is fully integrated into the project. Plan and track project level activities, including resources. Establish and maintain project standards Plan and manage submission activities, including SCS, SCE and Briefing Books Interaction with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings. Could take Indication or Trial Statistician responsibility as appropriate.
Master Degree in Statistics (or equivalent degree) with at least 7 years of pharmaceutical experience or PhD in Statistics with at least 4 years of pharmaceutical experience English (oral and written) Experience in all tasks of a Project Statistician (about 2-4 years) Proven knowledge and expertise in statistics and its application to clinical trials in at least one TA (preferably Oncology) Solid knowledge and experience in drug development process and HA guidelines. Proven Knowledge and expertise in statistics and its application to clinical trials Proven knowledge of drug development and Health Authority guidelines Knowledge of statistical software packages (e.g. SAS, S+) Very good project management skills Very good communication and presentation skills Good leadership skills. Ability to give effective guidance to Trial Statisticians and Project Programmer Good team player Good business ethics