CHC Global Medical Statistician Lead_ - _ Location Bogota - Colombia or Sao Paulo - Brazil_ About the job Our Team: - At Sanofi Consumer Healthcare, we have one shared mission - we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. To do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. Everything we do is centered around people’s interests - our consumers, our customers, healthcare professionals, and our employees - across the world. We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu. We aspire to become the best Fast Moving Consumer Health (FMCH) company in & for the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best._ Main responsibilities: - The Global Medical Statistician Lead (GMSL) is responsible for statistical support, including methodology and operational aspects of Consumer Health Care (CHC) Prescription to Non-Prescription Switch projects clinical studies (that includes interventional or non-interventional projects) and Real-World Evidence (RWE) studies, meta-analysis, post-hoc analysis. The statistical methodology includes inputs on several study documents such strategy plans, study outlines, study protocols, statistical analysis plans, statistical outputs, study reports and study results communications (publication, poster)._ - As a project team member, the GMSL represents statistics in international and multidisciplinary teams._ - As Statistical Project Leader in the global Clinical Development and Biometry team, you will provide leadership and guidance to the Switch CHC projects, being accountable for all methodological and statistical aspects. You will act as a statistical consultant within the company._ - Lead and provide input on the study design (including sample size) at the ideation level for CHC projects. - Lead decision making for appropriate statistical methodology at the ideation level for CHC projects. - Foster an environment/culture of learning and sharing good statistical practices within the team and outside the team. - Provide strong input on the scope of work dedicated to statistical activities outsourced to external vendors. - Lead and provide input on all statistical deliveries outsourced to external vendors. - Develop strong relationships with Statistical Service Providers, that could be either CROs or AROs. - Support claims through data generation including conventional clinical and nonclinical studies and emerging digital evidence generation capabilities. - Lead statistical aspects with stakeholders in collaboration with the cross-functional team (such as advisory board, health authorities). - Lead on the statistical aspects regarding study results dissemination such as study results presentation to senior management, publications, posters, congress, webinar. - Lead availability of statistical capabilities for regional and local CHC projects. - Follow OHG policies and SOPs and any relevant regulatory legislation and guidelines. - Ensure statistical oversight of registration dossiers for local, European and US registrations, Investigator Brochures (IBs), Clinical Trials Applications (CTAs), expert statements, and reports for regulatory purposes. About you - Experience: _Broad knowledge and good understanding of advanced statistical concepts and techniques; broad knowledge and experience in pharmaceutical clinical development such as submission or interactions with regulatory agencies or other external stakeholders_ - Education: _PhD/MS in statistics or related discipline with at least 10 years of pharmaceutical experience. Experience in CHC products would be a plus._ - Languages: Fluent spoken and written English (French or German would be a plus) 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, gender identity or Veteran status. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at ! LI-LATAM At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and cu