Associate Manager, Statistical Programming and Analytical Reporting

分享
  • 四川省-成都
  • 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:

  • Lead multiple studies and mentor junior programmer

  • In cooperation with SP/SB/PPL, plan and timely provide high quality centrailized 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 centrailized standard programming specifications (including SDTM and ADaM) for a study and implement study metadata.

  • Perform centrailized standard programming activities for statistical deliverables.

  • Perform quality control, as required per SOPs, for centrailized standard programming deliverables (including input in Validation Plan & QC documentation)

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

  • 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 requirments.

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

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!