Senior Statistical Programmer

Responsibilities

• Perform programming activities for all statistical deliverables including SDTM, ADaM, and Tables, Listings, and Figures (TLF).
• Write and provide programming specifications for SDTM, ADaM, and TLFs to fulfill study or project objectives.
• Deliver compliant CDISC data packages with all relevant documentation (e.g., aCRF, reviewers guide, define.xml) to meet Health Authority expectations.
• Review and provide feedback on study documents such as protocols, Case Report Forms (CRF), and Statistical Analysis Plans (SAP).
• Perform quality control for statistical programming deliverables and complete associated validation and QC documentation.
• Create core integrated clinical databases and pool SDTM/ADaM datasets across multiple studies within an asset.
• Ensure strict compliance with SOPs, industry standards, and regulatory guidelines.

Requirements

• 5-7 years of experience in statistical programming within clinical research, specifically including Vaccines experience.
• 3+ years of advanced technical experience with SAS (BASE, STAT, MACRO, GRAPH, and SQL).
• Proficiency in R programming.
• Deep expertise in CDISC SDTM and ADaM standards, including writing specifications and working with define.xml and Reviewers Guides.
• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or a related health science field.
• Highly effective oral and written English communication skills.
• Strong critical thinking and ability to organize multiple work assignments and establish priorities.

About the Company

Sanofi is an innovative global healthcare company dedicated to helping the world stay ahead of infectious diseases. We deliver more than 500 million vaccine doses a year and are constantly exploring new technologies to protect people and promote healthy communities. At Sanofi, we chase the miracles of science every day to make a real impact on millions of patients worldwide.