We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

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

Requirement:

• Lead multiple studies and mentor junior programmer
• In cooperation with SP/SB/PPL, plan and timely provide high quality centralized standard programming deliverables utilizing department standard tools and following department SOP’s and guidelines.
•   In cooperation with CoE PPL, ensure standards implemented consistently across studies at compound level. 
•   In cooperation with the SP/SB, provide the centralized standard programming specifications (including SDTM and ADaM) for a study and implement study metadata.
• Perform centralized standard programming activities for statistical deliverables.
• Perform quality control, as required per SOPs, for centralized standard programming deliverables (including input in Validation Plan & QC documentation)
• Provide standard programming related inputs to e-submission ADaM package and TLG.

Responsibility:

• Prepare items required for e-submission package including SDTM, ADaM and BIMO (FDA only) parts.
• Work closely with study team to provide feedback on study documents from submission perspective, such as dataset metadata file.
• Contribute to the submission standard process, template file and tools development/maintenance.
• Contribute working groups and initiatives e.g. for the development and testing of department tools.
• Review and provide feedback on study documents as per SOP and RACI requirements.
•   Build Data standards culture and expertise with readiness to evolving industry standards and regulatory submission requirements.