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Biomedical Data Stewardship Sr. Manager / ADaM Lead – Remote (JP9407)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Biomedical Data Stewardship Sr. Manager / ADaM Lead – Remote (JP9407)
Location: Thousand Oaks, CA (Remote)
Employment Type: Contract

Business Unit: CfDA Design & Innovation
Duration: 12 months with likely extension or conversion to FTE
Job posting date: 11/04/2021
Note: Other job titles include
Title: BMDS Sr. Manager - ADaM Lead


3 Key Consulting is hiring a Biomedical Data Stewardship Sr. Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:

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 Amgen 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
     
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 

Top 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
 
Employee Value Proposition:
DIPT team in cognitive analytics. We focus on natural language processing (text and opening documents), artificial intelligence and we create a lot of AI models to automate experiences. The team is very diverse.
 
Red Flags:

large gaps or inconsistencies in employment history

 
Interview Process:
phone or webex interview with some upper level management
  
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website 
www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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