**About us** At Sanofi, we chase the miracles of science to improve people’s lives. All our decisions are taken with our most important stakeholder in mind – the patients. Having a rich history of innovation that dates back over 100 years, Sanofi more than ever stays true to its commitment to transform the practice of medicine by providing potentially life-changing treatments and the protection of life-saving vaccines to millions of people. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases. ~ 43.07Bn€ Net Sales FY23 ~90 countries ~ 91K employees ~ 59 manufacturing sites ~ 20 R&D sites **About the role:** Identify the data sources and propose a data preparation approach , eg using sdtm data sets as an entry - Identifying, selecting, possibly combining the key variables - Support KRI list proposal and KRI definition, in accordance to KRI definition and study documents, write dataset programming specifications - Prepare the datasets needed for KRI, DQA analysis with good accuracy - Run Cluepoints reports (KRI, DQA) on a regular basis in accordance the study specificities - Understand abnormal pattern identified in the clinical study data, write DQA signals by diagnosing and explaining anomalies - Run additional analyses, in conjunction with B&P/TO teams to understand findings if appropriate - Provide elements of interpretation of findings/anomalies to the RBM central monitors to understand the signals - Prepare written report summarizing results (data findings and signals identified), if needed - Support the definition of actions to be taken to adapt the RBM strategy to signals - Closely collaborate with RBM Central Monitor, also interact with B&P/TO teams - Participate in the continuous improvement and development of RBM approach and operational processes - Ensure that appropriate documentation is produced and maintained for each study - Provide mentoring to Associate RBM Data Scientist/ RBM Data Scientist - Support and participate in developing and improving training material used both internally and externally **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, disability, 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) ! **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)