Job Overview- Principal or Senior Biostatistician required to work for Covance in Phases I-IV - You will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor - The Sponsor is a top 30 pharmaceutical company who has a strong and diverse product pipeline - Office based or home based anywhere in Central and Eastern Europe - You must be an experienced Lead Biostatistician 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 Covance FSP Senior Biostatistician. Our partner has an incredibly exciting and diverse pipeline including oncology, transplantation, urology and anti-infectives. The position offers a strong support network, flexible working solutions and the opportunity to raise your profile in the industry. If you are looking to strengthen your therapeutic expertise within oncology whilst gaining exposure to a Bio-Pharmaceutical working environment this is a fantastic opportunity. This is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a full-time home or office-based role anywhere within Central and Eastern Europe. What is FSP? At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP). As a Covance 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 Covance 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 Covance studies. With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at: https://www.covance.com/services/functional-service-provision.html 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. A comprehensive full job description is available.
Education/Qualifications- Master’s degree, equivalent, or higher in Biostatistics or related field
Experience- 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 (both verbal and written). PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE NO AGENCIES PLEASE MORE INFORMATION AVAILABLE ON REQUEST For a confidential discussion about this opportunity, please phone Peter Lewis on +44 (0) 1628 543 457. To apply, please click on the APPLY button. Keywords: FSP, Functional Service Provision, Clinical Analytics, FSPx, Statistician, Biostatistician, Stato, Statistics, Senior Biostatistician, Lead Biostatistician, Study Biostatistician, pharma, pharmaceutical, Sofia, Prague, Budapest, Vilnius, Warsaw, Bucharest, Moscow, Bratislava, Kiev, home based, field based, home-based, anywhere in CEE, anywhere in Central and Eastern Europe, flexible location, CDISC, SDTM ADaM, “Statistical Analysis Plan”, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, periodic safety update reports, oncology, rare diseases, Europe, cancer, Bulgaria, Czech Republic, Hungary, Lithuania, Poland, Romania, Russia, Slovakia, Ukraine, #LI-PL1, #LI-Remote, Remote, EMEA