Principal Biostatistician (Fsp)

Principal Biostatistician required to work for Labcorp Drug Development in Phases I-IIIb - You will be employed by Labcorp Drug Development within our FSPx department, outsourced to one Sponsor - Office based or home based anywhere in Italy - You must be an experienced Lead Biostatistician with experience gained within a CRO/Pharma/Biotech - Pro-active attitude, good communication and project management skills required Discover new opportunities to grow your career as a Labcorp Drug Development FSP Principal Biostatistician. Our partner works in 3 main areas, respiratory, rare diseases and cardiovascular. If you are looking to gain some experience of working within a pharmaceutical company, then this is a fantastic opportunity. What is FSP? : At Labcorp Drug Development, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP). As a Labcorp Drug Development employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Labcorp Drug Development has an FSP opportunity to match your area of expertise. Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Labcorp Drug Development studies. Job Primary Functions: - Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings - Perform project management activities for identified projects including resource planning, timelines and milestone management - Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants - Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians - Perform complex statistical analyses, quality check statistical analyses developed by other statisticians - Conduct overall statistical review of TFLs for complex studies prior to client delivery - Review CRF and other study specific specifications and plans - Perform complex sample size calculations under the supervision of more senior statistical staff - Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant - Provide statistic input and review of the CSR for complex studies - Preparation and review of randomization specifications and generation of randomization schedules - Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures - Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences - Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business - Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives - Represent the department during audits. Job Qualifications: - Master’s degree, equivalent, or higher in Biostatistics or related field - Previous experience of working as a Lead Biostatistician in either a biotech, CRO or pharma company. - Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis - Proven ability to effectively communicate statistical concepts - A good knowledge of the overall clinical trial process - Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials - Fluent in English language and Italian (both verbal and written). Looking to kick-start your career dedicated to improving health and improving lives? Then JoinThePursuit. MORE INFORMATION AVAILABLE ON REQUEST: For a confidential discussion about this opportunity, please phone Peter Lewis on 447917710602. To apply, please click on the APPLY button. NO AGENCIES PLEASE Keywords: Covance, Covance by Labcorp, Labcorp Drug Development, FSP, Functional Service Provision, Clinical Analytics, FSPx, Principal, Statistician, Biostatistician, Stato, Statistics, Senior Biostatistician, Study Biostatistician, pharma, pharmaceutical, Rome, Milan, Milano, home based, field based, home-based CDISC, SDTM ADaM, “Statistical Analysis Plan”, study