R&D
Wo deine Neugier die Wunder der Wissenschaft antreibt

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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Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.