Lead Biostatistical Programmer
il y a 2 jours
AbouttheJob JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand. Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovatio andmakinganimpactintheclinicalresearchspace,whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth. Activities Lead statistical programming activities for clinical trials within NITA and I-LCM projects. Create and validate ADaM specifications, ADaM datasets, and statistical outputs for Clinical Study Reports (CSR), iDMC reviews, ad hoc analyses, and scientific publications. Develop and validate CDISC-compliant datasets (ADaM, SDTM) to support regulatory submissions. Perform and oversee SAS programming, including development of macros and automated report generation tools. Validate and deliver define.xml, Analysis Data Reviewer’s Guide (ADRG), and full submission packages in accordance with current regulatory guidelines. Ensure compliance with international regulatory and data submission standards (e.g., FDA, EMA). Provide strategic oversight and guidance on statistical programming processes and industry best practices. Maintain a strong understanding of drug development processes and functional interdependencies (e.g., data management, clinical operations). Act as a key point of contact for cross-functional stakeholders, ensuring effective communication and alignment between biostatistics, clinical, and data teams. Mentor and support junior statistical programmers within the project team. About You At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values. Experience:Proven experience in statistical programming for clinical trials, including advanced proficiency in SAS. Hands-on experience with creation and validation of ADaM and SDTM datasets, statistical outputs, and submission deliverables. Prior experience with regulatory submission requirements and documentation (e.g., define.xml, ADRG, eCTD packages). Skills: Solid knowledge of CDISC standards (ADaM, SDTM), advanced SAS programming (macros, automation), strong understanding of the drug development lifecycle and cross-functional collaboration, strategic thinking, ability to work autonomously in an international environment. Education:Master's degree in Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field. Languages:Professional fluency in English (written and spoken). Comfortable working in an international and multicultural setting. WhyJoinUs? AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare. Here'swhatmakesusunique— Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel—offeringfull-service,functionalserviceprovider,andconsulting—enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney. Excellingwithcare meansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission. #J-18808-Ljbffr
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Lead Biostatistical Programmer
il y a 3 jours
Boulogne-Billancourt, France Excelya Temps pleinOverview Hybrid Operations, Statistics & Programming — Full time Boulogne-Billancourt, Île-de-France, France Description Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an...
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Lead Biostatistical Programmer
il y a 2 semaines
Boulogne-Billancourt, Île-de-France Excelya Temps pleinAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team. ...
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Lead Biostatistical Programmer: SDTM/ADaM
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Boulogne-Billancourt, France Excelya Group Temps pleinA dynamic clinical research company in Boulogne-Billancourt is seeking a Statistical Programmer to lead statistical programming activities for clinical trials. This role requires proven experience in SAS programming and a solid understanding of CDISC standards. The successful candidate will create and validate datasets, ensuring compliance with regulatory...
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Boulogne-Billancourt, France Atlantis Television Temps plein**Description du poste d’opérateur duplication / vérification** **Pour vous parler un peu de nous**: Atlantis Télévision est le leader français de la fabrication de programmes audiovisuels. Plateforme technique de référence pour les producteurs et les chaînes de télévision nous accueillons sur notre infrastructure de grands acteurs comme: TF1,...
