JOB DESCRIPTION Job Overview:Senior Statistical Programmers required to work for Covance as a Lead Statistical Programmer on studies in Phases I-IIYou will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor Office based in in any of our European or South African offices or home based anywhere in Europe or South AfricaYou must have previous Lead experience as a Statistical Programmer within a biotech, CRO or pharma companyStrong Oncology experience in Phases I and II would be an advantageOpportunities to develop and progressDiscover new opportunities to grow your career as a Covance FSP Senior Statistical Programmer. Covance FSP are looking to hire experienced Lead Statistical Programmers.Our partner has an incredibly exciting and strong pipeline with over 45 ongoing oncology studies in Phases I and II. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Lead expertise whilst gaining exposure to a 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 Europe or South Africa.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: Job Primary FunctionsPerform the role of the Lead Statistical ProgrammerPlan, 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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLsProduce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMsDevelop specifications for SDTMs and ADaM datasetsReview SAPs and TFL shells from a programming perspective for studiesMentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLsPresent and share knowledge at department meetingsRespond to QA and client audits, and support qualification auditsIdentify processes within programming that will increase productivity, quality and efficiencyEducation/Qualifications:BSc in a computing, life science, mathematical or statistical subjectExperience:Previous Lead experience as a Statistical Programmer within a biotech, CRO or pharma companyPrevious oncology experience essentialPositive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environmentGood organization skills and the ability to prioritize own workSelf motivation and ability to work independentlyA cooperative and team-oriented approachCandidates must be fluent in English language (both verbal and written)PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSENO AGENCIES PLEASE
Senior Statistical Programmer - FSP in Bucuresti
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