Principal Biostatistician

Position Summary:\nThe Principal Biostatistician is responsible for overseeing biostatisticians within the Data\nManagement and Statistics Department staff to ensure accurate and timely completion of all\nstatistical activities. In addition, the Principal Biostatistician provides expertise across several\ntherapeutic areas in all phases of clinical trials and combines statistical expertise, technical\nknowledge on data processing and the ability to handle complex scientific/medical aspects of the\nstudy to ensure all activities are carried out in compliance with the clinical study’s requirements,\nthe Company’s processes as well as the Sponsor’s processes and regulatory requirements, as\napplicable.\n\nMain Duties & Responsibilities:\nEnsures all biostatisticians are adequately technically qualified, as well as trained on\nCompany processes related to activities assigned Is responsible, for coordinating the biostatisticians team to ensure the accurate and timely completion of all statistical activities for assigned projects.\nEscalates and acts on risks in relation to the milestones of pending statistical activities\nActs as the study assigned biostatistician for complex studies, providing statistical\noversight and attending relevant project meetings\nMonitors project budgets and tasks, and escalates issues to the Director, Biometrics, as\nappropriate\nReviews Statistical Analysis Plans (including mock TFL shells), as appropriate\nWorks closely with the Clinical Science Department and other Company Departments, to\nprovide statistical expertise and lead the statistical analysis to ensure that the study needs\nare fulfilled\nProvides input to deliverables prepared by less experienced biostatisticians in the\ndepartment, as needed\nReviews and approves scientific abstracts, posters and manuscripts, prepared by less\nexperienced biostatisticians in the department\nIn collaboration with the Senior Biostatistician, provides statistical expertise on the\nprojection of milestones, drug expectations and other statistics-related tasks\nComplies with the Company's Quality and Information Security Management Systems\nand applicable national and international legislation, including legislation for data\nprotection\n\nProfessional Experience Requirements:\n\n− Required: 6 years of biostatistics experience in a CRO, a pharmaceutical or equivalent\norganization\n− Desirable:\no Strong experience in statistical computing (R/SAS or similar statistical\nprogramming language)\no Participation in studies with FDA submissions (CDISC standards) and previous\nworking experience with phase III studies with multiple interim analyses will be\nconsidered as a strong plus