Responsibilities:

  • Accountable for all core SP deliverables (SDTM, ADAM, TFLs)
  • May also be accountable for clinical programming tasks
  • Provides ongoing data review by providing programmed edit checks

Qualifications:

  • BS/BA degree and 10+ years of experience in analyzing clinical data OR MS in statistics or related area and 7+ years of experience
  • Experience with FDA submissions and the provision of data submission packages
  • Deep knowledge of the SAS programming language

Core Competencies:

  • Strong understanding of clinical development processes and regulatory expectations
  • Ability to lead and influence in a matrixed environment
  • Demonstrated ability to balance urgency with quality

Mineralys Therapeutics

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company that appears to be mid-sized, offering a collaborative and fast-paced environment.

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