Biomedical Data Stewardship, Director

South San Francisco, California
Aug 18, 2018
Required Education
Position Type
Full time

BMDS provides critical expertise and leadership in the design, planning, development, adoption, consultation, and governance of Data Element Standards (DES). The Head of BMDS drives the creation and adoption of innovative approaches and strategic thinking in the development and delivery of DES, and provides advice and input to BMDS and other functional departments. The Head of BMDS collaborates and partners with TA Heads, functional leads, and innovative development programs and clinical trial teams to communicate and drive the adoption and reuse of clinical trial-related standards.

Key responsibilities include the following:

Develop a Clinical Data Standards Center of Excellence

  • Promotes innovative DES development strategies and fit-for-purpose prioritization approaches that address Amgen's pipeline, program, product, study team, TA, and other key stakeholders requirements
  • Supports the planning, design, development, delivery, adoption and governance of DES
  • Implements an end-to-end clinical data standards philosophy that provides maximum transparency and data quality
  • Initiates and contributes to the continuous improvement of clinical data standards and CfDA (Center for Design & Analysis)/D&Is operational efficiency and effectiveness
  • Actively participates in external professional organizations like CDISC and TransCelerate to help develop and promote Industry clinical data standards best practices

Provide strategic data stewardship leadership

  • Supports complex planning, prioritization and development decision-making throughout DES lifecycle
  • Identifies priorities, trade-offs, risks, and gaps in standards development strategy
  • Identifies opportunities to apply lessons learned and best practices to create efficiencies and optimize resource utilization

Builds Cross-functional Network

  • Brings the right functions together at the right time and integrates cross-functional input to facilitate end-to-end DES development
  • Serves as a SARP (Study Analysis Reporting & Publications) Global Network lead for accelerating the development of TA standards
  • Partners with TAs, GSO (Global Study Organization) , GRW (Global Regulatory Writing), and other key stakeholders when working on TA standards development
  • Influences the adoption of novel or innovative approaches to standards development
  • Ensures governance of standards through DESG (Data Element Standard Governance) is effectively represented by key stakeholders
  • Participates in the CDISC TAUG (Clinical Data Interchange Standards Consortium Therapeutic Area User Guide) public reviews on behalf of Amgen and lead the cross-functional teams in the review, comment, documentation, and submission of opinions and findings
  • Liaises with key stakeholders in Protocol/SAP (Study Analysis Plan)/DC (Data Capture)/SDTM (Study Data Tabulation Model)/ADaM (Analysis Data Model)/TFL (Tables, Figures, and Listings) to ensure end-to-end standards philosophy is embedded

Basic Qualifications

Doctorate degree and 4 years of Clinical Trial experience
Master's degree and 8 years of Clinical Trial years
Bachelor's degree and 10 years of Clinical Trial experience

Preferred Qualifications

  • Bachelor's degree or higher, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
  • 10 years data modelling, data transformation and data management
  • 10 years of experience in leading the implementation of clinical data standards in a regulated environment in a Clinical Development setting
  • Drug Development (pre-, early, late phase clinical trials and/or observational study) experience in related industries or academic research
  • Experience of data collection through to analysis & reporting
  • Budget and resource planning
  • Project planning and management
  • Process improvement and operational effectiveness leadership
  • Development of policies and SOPs
  • End-to-end clinical standards development knowledge and experience
  • Ability to integrate and synthesize cross-functional input as it relates to standards planning, development, adoption, and use and apply decision science framework to facilitate data-driven decision making
  • Understands and can communicate implications of cross-functional inputs to teams
  • Experience with innovative development approaches and understanding of how / when to apply them (fit-for-purpose approach)