Job Description

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
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Languages:
English: Highly effective communication, both oral and written
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
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Skills Required