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.