R&D
Là où votre curiosité fait avancer les miracles de la science

Main responsibilities:

• Perform programming activities for all statistical deliverables (i.e.: SDTM, ADaM, Tables Listings and Figures (TLF)) for various analyses within a study (e.g.: interim/final analyses, internal or external data monitoring committees, statistical surveillance) or within a project (i.e.: ISS, ISE, ISI, DSUR, PBRER,…)

• Review and provide feedback on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and mock TLFs

• Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives

• Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations

• Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)

• Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.

• Program exploratory and/or post’hoc analyses with minimum specifications

• Create core integrated clinical database, pooling SDTM/ADaM datasets across several studies within an asset

• Ensure compliance to SOP's, standards, and guidelines.

About you

You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:

• Experience:

• • 5-7 years experience in statistical programming clinical research with some Vaccines experience (designs, endpoints, statistical methods, …)

  • SAS (>3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programming

  • Experience programming CDISC SDTM/ADaM datasets and notably vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide)

  • Experience pooling data from multiple studies according to existing specifications

  • Experience planning and drafting specifications for pooling data from multiple studies

• Skills:

• • Good understanding of processes associated with clinical trials

  • Ability to independently create specifications

  • Knowledge of descriptive statistics

  • Demonstrate interpersonal skills necessary for effective teamwork

  • Demonstrate ability to organize multiple work assignments and establish priorities

  • Demonstrate critical thinking skills beyond simply following directions or specifications

• Education:

• • Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience

  • undefined

• Languages:

• • English: Highly effective communication, both oral and written

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Toujours Progresser. Découvrir l’Extraordinaire.

Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.

Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.