**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 **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. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)