Manager - Data Standards, SDTM Programming

Added
10 days ago
Type
Full time
Salary
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Related skills

regulatory requirements cdisc sdtm adam cdash

📋 Description

  • Actively participating with a cross-functional team of subject matter experts to define one more of
  • Participating in a cross-functional team of subject matter experts to define one more of the
  • Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions
  • Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM
  • Develop training materials to the organization on the proper use of standards in pipeline activities
  • Communicate ongoing standard development activities across the organization

🎯 Requirements

  • University degree in computer science, data science, biology or statistics and master's degree with
  • Experience with SDTM programming is required as well as experience with leading development of
  • Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
  • Experience with CDASH and active participation in CDISC teams recommended
  • Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
  • Fluent language skills in English written as well as spoken are necessary, German language skills

🎁 Benefits

  • A diverse work environment where you can have a real impact
  • An open corporate culture
  • An attractive salary
  • An intensive onboarding process with a mentor at your side
  • Flexible work models for a healthy work-life balance
  • Corporate health management that offers comprehensive health and exercise programs
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