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Lead Biostatistical Programmer H/F Excelya
- Boulogne-Billancourt - 92
- CDI
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
Les missions du poste
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.
WhyJoinUs?
AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.
Here'swhatmakesusunique-
Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.
Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.
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.
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
La carte
35 Rue de Paris
92100 Boulogne-Billancourt
Hellowork a estimé le salaire pour cette offre
Cette estimation de salaire pour le poste de Lead Biostatistical Programmer H/F à Boulogne-Billancourt est calculée grâce à des offres similaires et aux données de l’INSEE.
Cette fourchette est variable selon expérience.
Salaire brut min
43 400 € / an 3 617 € / mois 23,85 € / heureSalaire brut estimé
52 500 € / an 4 375 € / mois 28,85 € / heureSalaire brut max
67 500 € / an 5 625 € / mois 37,09 € / heureCette information vous semble-t-elle utile ?
Merci pour votre retour !
Publiée le 02/11/2025 - Réf : d4a25ba4-674a-4dc3-a07f-ee5da21b8fc6
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Lead Biostatistical Programmer H/F
- Boulogne-Billancourt - 92
- CDI
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