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 current 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 and check out our Diversity Equity and Inclusion actions at