Project Programming Lead

Job Title Project Programming Lead Location Morristown, NJ Overview As Project Programming Lead within our Vaccines Biostatistical Sciences team, you'll lead the scientific programming of large or a few small projects from our vaccines portfolio, bringing data to life along the development value chain. Assume responsibility for all scientific programming activities related to a late‑phase clinical development project or multiple projects in early or post‑marketing phases. The incumbent provides technical and operational leadership and is accountable for all programming activities for the related project(s). Additionally, assume transversal responsibility for outsourcing operation management. About Sanofi We are an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people worldwide. Basic Qualifications Master’s degree in Statistics, Mathematics, Computer Science, or a related health‑sciences field. 7+ years of hands‑on experience in SAS and R programming, proficiency in CDISC standards (SDTM/ADaM), and regulatory submission requirements. Preferred Qualifications Proven success performing, coordinating, and overseeing the preparation, execution, reporting, and documentation of all study and project‑level asset development programming deliverables in a global setting, including experience with third‑party vendors. Demonstrated leadership with interpersonal skills necessary for effective teamwork in a multicultural setting, ability to embrace and lead change, curiosity to innovate, and a drive to improve team practices where it adds value. Experience implementing automation and digital transformation initiatives. Fluent in English; additional languages are a plus. Main Responsibilities Lead scientific programming deliverables – provide leadership, guidance, and hands‑on support to ensure high‑quality, timely programming outputs while ensuring compliance with internal standards, SOPs, and regulatory requirements. Manage project planning and resources – plan and track programming activities, timelines, and resource utilization in a global setting. Ensure standardization and consistency – maintain consistency in specifications and programming deliverables across individual studies and integrated analyses. Drive regulatory submissions – lead regulatory submission activities, including electronic submission packages, ensuring CDISC data packages comply with health authority expectations (FDA, PMDA, CDE, KFDA, etc.). Oversee outsourcing engagements and guide team interactions with external resources. Collaborate cross‑functionally – partner effectively with project statistician(s) and participate in clinical project meetings, contributing relevant inputs. Assume transversal responsibilities, contributing to process improvement or ensuring outsourcing operation management, coordinating CRO partnerships, ensuring operational quality and timely delivery through KPI follow‑up, leading lessons‑learned meetings, and maintaining partnership governance and shared IT environments (e.g., Teams or SharePoint sites). Mentor – provide guidance to junior staff on programming techniques and standards implementation. Benefits Bring the miracles of science to life alongside a supportive, future‑focused team. Discover endless opportunities to grow your talent and drive your career, whether through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family with a wide range of health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real‑world needs. Help improve the lives of millions of people globally by making drug development quicker and more effective. Work at the forefront of drug discovery, harnessing cutting‑edge AI, data, and digital platforms to push the boundaries of science. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found within the company portal. #J-18808-Ljbffr BioSpace