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:

Job Summary

Leads compound level or multiple studies CoE project and provides high quality and timely delivery of standard datasets, outputs, and e-submission packages.

Major Duties and Responsibilities

ØLead multiple studies and mentor junior programmer.

ØIn 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.

ØIn cooperation with CoE PPL, ensure standards implemented consistently across studies at compound level.

ØIn cooperation with the SP/SB, provide the centralized standard programming specifications (including SDTM and ADaM) for a study and implement study metadata.

ØPerform centralized standard programming activities for statistical deliverables.

ØPerform quality control, as required per SOPs, for centralized standard programming deliverables (including input in Validation Plan & QC documentation).

ØProvide standard programming related inputs to e-submission ADaM package and TLG.

ØPrepare items required for e-submission package including SDTM, ADaM and BIMO (FDA only) parts

ØWork closely with study team to provide feedback on study documents from submission perspective, such as dataset metadata file

ØContribute to the submission standard process, template file and tools development/Maintenance.

ØContribute working groups and initiatives e.g. for the development and testing of department tools.

ØReview and provide feedback on study documents as per SOP and RACI requirements.

ØBuild Data standards culture and expertise with readiness to evolving industry standards and regulatory submission requirements.

Required Education/Experience:

·Bachelor's or master's degree in statistics, computer science, or relevant filed

·At least 5 year working experience in clinical trial development

·Ability to support study requirements with challenging timelines under direct supervision by the PPL/PTAH.

·Experience in delivering one or more submisisons to rgulatory authorities globally

·Knowledge on regulatory requirements, understanding of pharmaceutical clinical development and ability to lead regulatory submissions

·Good SAS and R programming skill required

·Experience in Open Source and/or python preferred.

·Great potential/Capability to provide programming leadership to cross -functional teams at the study level

·Effective English verbal and written communication skills in relating to colleagues and associates both inside and outside the organization control approach to work.

·Ability to work effectively in a multi-cultural context as a good team member.

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!