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Dear Allstat, Happy New Year to Everyone! CK Clinical is currently recruiting for a Project Biostatistician to work for a Blue-Chip pharmaceutical organisation in the EU on a permanent basis. The purpose of the Project Statistician is to assume the role of an independent Clinical Development Program Statistician for the assigned trial worldwide, together, with keeping oversight and coordinating the activities of other statisticians within the assigned project. Responsibilities: * Provides consultation and advice in quantitative/statistical, experimental design, and data management issues. Works with the clinical monitor and international teams to develop clinical protocols, analysis plans and final study reports for clinical development projects. You will also plan, coordinate, and produce statistical analyses and summaries in support of product development. * Member of core clinical cluster team, attend meetings as and coordinates activities with internal data management and programming staff, medical writing and regulatory affairs. * Be the statistical leader and project manager for all deliverables globally for a clinical development program * Ensure that clinical development program (or parts assigned) meets scientific, regulatory, quality, and commercialization requirements. * Perform matrix management of project team, and mentor staff as required. * Plan and track project level activities, including resources. * Establish and maintain project standards (master analysis plan, full development project specifications). * Plan and manage submission activities. * Interact with Clinical Data Management as appropriate. * Interact 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. * Coach and mentor statisticians Interested applicants should hold an MSc or Ph.D. in Statistics, Biostatistics or Mathematics with proven industrial experience (pharmaceutical industry preferred). You should also be able to demonstrate: * Sound knowledge of statistical applications to clinical trials. * An awareness of appropriate regulations and guidance documents. * Good SAS programming knowledge. * Strong problem solving skills and sound statistical judgment. Technical capability to address common statistical problems arising in work. * Attentiveness to detail. * Strong interpersonal skills. Effective oral & written communication skills. * Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings. * Ability to complete complex tasks on a timely basis with minimal supervision; well organized. * Excellent project management skills/leadership skills. For immediate consideration, please contact Priya Mukherjee on +44(0)1438 870028 or email an updated CV to [log in to unmask]<mailto:[log in to unmask]> Salary on offer is competitive and can be discussed upon application. I look forward to hearing back from you. Best regards, Priya Priya Mukherjee BSc (Hons) MIRP CertRP Senior Consultant CK Clinical Limited 9 High Street Stevenage Old Town Hertfordshire SG1 3BG DD: +44 (0)1438 870028 Mobile: +44 (0) 7714 288632 Tel: +44 (0)1438 743047 Fax:+44 (0)1438 723800 You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.