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Biomedical Data Stewardship Sr. Manager

Thousand Oaks, CA

“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations tstaff augmentation external workers whqualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship tthis company, its operations, or its staff.”

Top 3 Must Have Skill Sets:            
  • Bachelor’s degree or equivalent in statistics/biostatistics, programming, life science, computer science, business administration, or related discipline, or equivalent combination of education and experience
  • 8+ years knowledge/experience in biostatistics or programming in the Pharmaceutical/Biotech industry
  • 3+ years of CDISC ADaM implementation

Summary
Department: Biomedical Data Stewardship (BMDS)

Reports to: Director, BMDS

Key Responsibilities:
  • Support development and maintenance of data element standards (DES) with a focus on and Analysis Data Model (ADaM) standards
  • Provide strategic direction in the adoption and implementation of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and ADaM standards
  • Stay abreast of latest developments and requirements in the field of DES, CDISC, and regulatory guidance/practice
  • Support process improvement initiatives related to the governance of ADaM standards
  • Ensure that changes to standards are implemented consistently and in a timely manner
  • Support development and delivery of trainings, awareness presentations, and/or communications about the standards
  • Provide DES expertise to stakeholders across R&D
  • Adhere to this company Policies and SOPs when developing, maintaining, and governing data standards
Key Skills / Knowledge:
  • Experience defining, managing, and governing ADaM data standards; aptitude for data standards and data standardization
  • Experience working in collaboration with global cross-functional teams with demonstrated effective communication skills (written and oral) and ability to influence decision making
  • In-depth knowledge of CDISC SDTM and ADaM standards
  • Experience implementing SDTM and ADaM standards in a practical setting across multiple study designs
  • Experience creating SDTM and ADaM submission packages
  • Understanding of CDISC Therapeutic Area User Guides (TAUGs)
  • Knowledge of project management, documentation writing, training, and compliance
  • Experience developing and maintaining standards implementation guides

Qualifications:
Basic Qualifications
Bachelor’s degree or equivalent in statistics/biostatistics, programming, life science, computer science, business administration, or related discipline, or equivalent combination of education and experience
8+ years knowledge/experience in biostatistics or programming in the Pharmaceutical/Biotech industry
3+ years of CDISC ADaM implementation

Preferred Qualifications
  • Master’s degree or equivalent in statistics/biostatistics, programming, life science, computer science, business administration, or related discipline
  • 10 years of work experience in biostatistics or programming in the Pharmaceutical/Biotech industry
  • 5+ years of CDISC ADaM implementation
  • 3+ years of experience in a global organization

"This posting is for Contingent Worker, not an FTE"

 

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