Job TitlePrincipal Biostatistician (FSP)Location:AustriaBelgiumBulgariaCzech RepublicEstoniaFranceGermanyGreeceHungaryIrelandItalyLatviaLithuaniaNetherlandsPolandPortugalRomaniaSerbiaSlovakiaSouth AfricaSpainSwedenUKDescription Principal Biostatistician required to work for Labcorp Drug Development in Late Phases Clinical Trials You will be employed by Labcorp Drug Development and work within our FSPx department 100% dedicated to one Sponsor The Sponsor is a top 20 pharmaceutical company who has a strong and diverse product pipeline Office based in any of our European or South African offices or home based anywhere in Europe or South Africa 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 Labcorp Drug Development FSP Principal Biostatistician. Our partner has a high-profile pipeline within oncology. 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 (alongside other therapy areas) whilst gaining exposure to a Bio-Pharmaceutical working environment this is a fantastic opportunity.This is an incredibly exciting time to be joining Labcorp Drug Development as we continue to grow and expand. This is a full-time home or office-based role anywhere within Europe or South Africa.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.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://drugdevelopment.labcorp.com/services/functional-service-provider.htmlJob 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 (both verbal and written). Looking to kick-start your career dedicated to improving health and improving lives? Then #JoinThePursuit.MORE INFORMATION AVAILABLE ON REQUESTFor a confidential discussion about this opportunity, please phone Mirko Argentiero on +39 345 0383908 or send an email at firstname.lastname@example.orgTo apply, please click on the APPLY button.NO AGENCIES PLEASEKeywords:Covance, Covance by Labcorp, Labcorp Drug Development, FSP, Functional Service Provision, Clinical Analytics, FSPx, Adaptive Design, Umbrella, Platform, “Bayesian analysis”, Principal, Statistician, Biostatistician, Stato, Statistics, Senior Biostatistician, Study Biostatistician, pharma, pharmaceutical, Bloemfontein, Vienna, Brussels, Sofia, Prague, Paris, Berlin, Athens, Budapest, Dublin, Rome, Vilnius, Amsterdam, Warsaw, Lisbon, Bucharest, Moscow, Bratislava, Madrid, Bern, Basel, Kiev, Slough, Berkshire, London, England, Edinburgh, United Kingdom, Cambridge, Swansea, Sheffield, Manchester, Alderley Edge, Birmingham, home based, field based, home-based UK Anywhere, anywhere in England, anywhere in Scotland, anywhere in Wales, anywhere in Ireland, 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, Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sweden, Ukraine, UK , #LI-PL1, #LI-Remote, Remote, EMEALabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/hipaa-privacy/web-privacy-policy) . 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Principal Biostatistician (FSP) in Bucharest, Romania in Bucuresti
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