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Company Description
Eurofins Scientific is an international life sciences company,providing a unique range of analytical testing services to clientsacross multiple industries, to make life and our environment safer,healthier and more sustainable. From the food you eat, to the water youdrink, to the medicines you rely on, Eurofins works with the biggestcompanies in the world to ensure the products they supply are safe,their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical andcosmetic product testing and in agroscience Contract ResearchOrganisation services. Eurofins is one of the market leaders in certaintesting and laboratory services for genomics, discovery pharmacology,forensics, advanced material sciences and in the support of clinicalstudies, as well as having an emerging global presence in ContractDevelopment and Manufacturing Organisations. The Group also has arapidly developing presence in highly specialised and molecular clinicaldiagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory inNantes, France to 55,000 staff across a decentralised andentrepreneurial network of 900 laboratories in over 50 countries.Eurofins offers a portfolio of over 200,000 analytical methods toevaluate the safety, identity, composition, authenticity, origin,traceability and purity of biological substances and products.
Job Description
Basic Function and Scope of Responsibility:
The Biostatistics Analyst is primarily responsible for appliedstatistics in support of clinical data analysis plus new assay/method,design and validation efforts for product development.
Essential Job Duties:
Biostatistics Analyst - Minimum
Provide biostatistical support for RD projects requiringstatistical analysis of clinical data, and programming and handlingomics data.Work closely and effectively with Bioinformatics BioPharmaleadership to ensure that RD projects are progressing, andmilestones are achieved pursuant to organization and/or clienttimelinesCommunicate effectively with both internal and external clientsregarding technical issues/projectsWrite verification/validation reports and SOPs in accordance withViracor Eurofins' established guidelinesServe as team member on various ongoing and future new test ideageneration projectsDevelop and maintain an effective working relationship with clinicallaboratory team to allow effective, coordinated assay transitionfrom the RD phase to clinical useDevelop an effective working relationship with RegulatoryAffairs/Quality Assurance to assure RD laboratory is in compliancewith Viracor Eurofins' established guidelines for documentation,quality and safetyWhen appropriate, conduct regular individual meetings with RDScientists that focus on biostatistical requirements related theirrespective responsibilities and project prioritiesCommunicate program objectives to cross-functional teams (clinicallaboratory, regulatory teams)Commitment to a high quality of work and at the same a high level ofproductivityMaintain current knowledge of advances in pertinent fields, throughattending lectures, seminar, professional conferences and coursesRegularly contribute to laboratory team meetings that focus onassociate training, associate development and continuous improvementin laboratory processesPreparation of poster presentations for national scientific meetingsPrepare manuscripts for publication in peer reviewed journalsRepresent department and the organization favorably an inaccordance with established Company standards and associateattributes at all timesActive participation in team and company meetingOther duties as assigned by managementComplete Media Lab and other assigned departmental trainingPerformance Expectations:Develop and maintain an effective/professional working relationshipwith external customers and internal colleagues to provide the bestservice possibleRepresent department and organization professionally and favorablyand in accordance with established Company standards and associateattributes at all timesOther duties as assigned by managementSenior Biostatistics Analyst - Fully meets the responsibilities ofBiostatistics Analyst plus the following:
Leading the Biostatistical analysis and RD efforts to analyze theclinical data.Actively support our Pharma clients and participate in the studydesignQualifications
Essential Knowledge, Skills and Abilities:
Biostatistics Analyst - Minimum
MS degree (or Ph.D.) in Biostatistics, Public Health, Bioinformatics
Expertise in the use of frequentist statistics, labor