SAS Programmer

SAS Programmer

SAS Programmer

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Accentuate Staffing is working with a small Biotech company in the RTP area to help fill a SAS Programming role due to tremendous growth in their organization.  This is a great opportunity to be part of something from the ground up!

Responsibilities:

  • Provide support to their CROs from the time of database build through final statistical outputs as well as supporting NDA submission related activities.
  • Review and provide feedback on database builds ensure that data required per protocol is being captured correctly
  • Review and provide feedback on edit specifications
  • Review and provide feedback on Data Management Plan
  • Review and provide feedback on pre-builds for the database
  • Review and provide feedback on of eCRF & aCRF
  • Extract SAS datasets from the EDC system and produce internal SAS programs for simple looks at the data as it is being entered
  • Review and provide feedback on SDTM annotated CRFs and SDTM specs
  • Review and provide feedback on SAP/mock shells
  • Review and provide feedback on ADaM specifications
  • Review and provide feedback on SDTM & ADaM Datasets
  • Review and provide feedback on TLFs
  • Ensure SDTM/ADaMs not only follow IGs and meet regulatory needs but also follow internal Novan standards so that studies fit together at the time of integration
  • Submission related experience

Requirements:

  • The ideal candidate would be a resource who has had experience in DM/clinical programming and Statistical Programming.
  • Most important that they have extensive experience in SDTM and ADaM requirements
  • Experience with submission requirements

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