JOB DESCRIPTION Job Overview:Principal Statistical Programmer required to work for Labcorp Drug DevelopmentYou will be employed by Labcorp Drug Development working in our late phase (II-IV) full-service group with the opportunity to work across several therapeutic areasHome based anywhere in Europe or South AfricaYou must have previous experience of working as a Lead Statistical Programmer in either a biotech, CRO or pharma company using the SAS programming languageCandidates must be fluent in English language (both verbal and written)Join our growing team and discover your extraordinary potential by working as a Labcorp Drug Development Principal Statistical Programmer. As a Principal Statistical Programmer at Labcorp Drug Development you will be responsible for all statistical programming deliverables of one or more complex clinical trials. You will work in our internal late phase full service group so you will enjoy a varied role working for different sponsors across several therapeutic areas within phases II-IV. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are an experienced Lead Statistical Programmer and you are looking for your next career move then this is a fantastic opportunity. This really is an incredibly exciting time to be joining Labcorp Drug Development as we continue to grow and expand. This is a permanent, full-time office or home-based role anywhere within Europe or South Africa.Job Primary FunctionsPerform the role of the Lead Statistical Programmer.Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLsProduce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMsDevelop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of company and Client standardsReview SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspectiveMentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processesPresent and share knowledge at department meetingsRespond to QA and client audits and support qualification auditsContribute to proposal activities and participate in bid defenses meetings in order to win new businessContinually identify and suggest ways to improve the efficiency, quality and productivity of statistical programmingEducation/Qualifications:BSc, preferably in computing, life science, mathematical or statistical subjectExperience:You must have previous experience of working as a Lead Statistical Programmer on complex studies in either a biotech, CRO or pharma company using SASKnowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standardsExcellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate project teams and the ability to delegate and prioritize work to meet project timelinesSelf motivation and ability to work independently without appreciable directionAbility to apply extensive technical expertise and the full knowledge of other related disciplines to provide consultancy and advice on programming and wider related issues to other departments and disciplinesExcellent problem solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possibleA willingness to make decisions seeking advice from statistical programming managers or directors to confirm decisions when necessaryA proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across themCandidates must be fluent in English language (both verbal and written)NO AGENCIES PLEASE
Principal Statistical Programmer - CDS in Bucuresti
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