Aller au contenu principal
Excelya recrutement

Lead Biostatistical Programmer H/F Excelya

  • Boulogne-Billancourt - 92
  • CDI
  • Bac +5
  • Industrie Pharmaceutique • Biotechn. • Chimie
Lire dans l'app

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

Localiser le poste

Publiée le 02/11/2025 - Réf : d4a25ba4-674a-4dc3-a07f-ee5da21b8fc6

Lead Biostatistical Programmer H/F

Excelya
  • Boulogne-Billancourt - 92
  • CDI
Publiée le 02/11/2025 - Réf : d4a25ba4-674a-4dc3-a07f-ee5da21b8fc6

Finalisez votre candidature

sur le site du recruteur

Créez votre compte pour postuler

sur le site du recruteur !

Ces offres pourraient aussi
vous intéresser

Safran recrutement
Voir l’offre
il y a 12 jours
Generali France recrutement
Generali France recrutement
Saint-Denis - 93
CDI
Télétravail occasionnel
Voir l’offre
il y a 8 jours
L'Industrie recrute recrutement
Voir l’offre
il y a 7 jours
Voir plus d'offres
Les sites
L'emploi
  • Offres d'emploi par métier
  • Offres d'emploi par ville
  • Offres d'emploi par entreprise
  • Offres d'emploi par mots clés
L'entreprise
  • Qui sommes-nous ?
  • On recrute
  • Accès client
Les apps
Application Android (nouvelle fenêtre) Application ios (nouvelle fenêtre)
Nous suivre sur :
Informations légales CGU Politique de confidentialité Gérer les traceurs Accessibilité : non conforme Aide et contact