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Biomedical Data Stewardship Senior Manager – ADaM Lead – REMOTE - (JP9407)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Biomedical Data Stewardship Senior Manager – ADaM Lead – REMOTE - (JP9407)
Location: Thousand Oaks, CA. (100% REMOTE)
Employment Type:  Contract
Business Unit: CfDA Design and Innovation
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 11/4/2021


3 Key Consulting is hiring a Biomedical Data Stewardship Senior Manager - ADaM Lead for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
****Remote open to any time zone.****
****Department: Biomedical Data Stewardship (BMDS)
****Reports to: Director, BMDS
  • 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 client Policies and SOPs when developing, maintaining, and governing data standards

Top Must Have Skills:
  • 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

Basic Qualifications:
  • 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
  • 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

Red Flags:
large gaps or inconsistencies in employment history

Interview process:
Video Skype Panel Interview


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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