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Metadata Engineer - Statistician

Metadata Engineer - Statistician

Purpose

Lead global and product specific analysis (ADaM) metadata development in collaboration with CDISC standards development teams (Therapeutic Area, Foundational and SHARE (Metadata Repository) teams).

Key Business Understanding

  • Understand clinical development and regulatory data submission processes.
  • Understand evolving research standards.
  • Understand the global metadata landscape.
  • Understand clinical development and regulatory data submission processes.
  • Understand concept modeling.

Specialized Knowledge/Skills

  • Expertise in the biomedicine and/or conduct of clinical research
  • Understanding of ADaM philosophy and application, preferred but not required
  • SAS and/or SQL programming knowledge
  • Exposure to Patient-level data and metadata
  • Technical skills/knowledge in one or more of the following: multivariate analysis, regression analysis and forecasting, sampling, data modeling, R programming, machine learning, SPSS
  • Strong facilitation and consensus building skills across important constituencies
  • Ability to negotiate and gain acceptance by others in time-sensitive, high pressure situations.
  • Self-starter, works independently with moderate amount of supervision.
  • Ability to communicate written and verbal information in a clear, professional manner.  Able to make formal presentations to senior management and staff.
  • Skilled in general computer applications, such as Microsoft Office.
  • Agrees to the CDISC Code of Conduct and Intellectual Property policies.

Key Operational Responsibilities

  • Leads definition of new metadata, particularly ADaM.
  • Contributes to the refinement of governance.
  • Initiates and drives to completion any necessary additions and updates to metadata related to analysis.
  • Takes a strong leadership role in analysis metadata requirements gathering sessions.
  • Works with individuals and teams in preparing new analysis metadata proposals and metadata change requests.
  • Advocates for reusability, ensuring that project teams are aware of data elements that are available. 
  • Ensures that new analysis metadata proposals and proposed metadata changes are complete and ready to circulate for wider review.
  • May lead the overall review of metadata proposals and changes, monitors review comments, and determines whether conflicting comments require escalation with the relevant project manager on issues related to analysis.
  • Maintains healthy communication patterns with colleagues and organizations, subject matter experts and technical harmonization experts.
  • Follows the CDISC standards development process and all applicable SOPs.

Education

  • Master's degree in Statistics/applied statistics or Bachelor’s degree in Biostatistics and 3-5 years of industry experience
  • Position reports to the VP, Standards Development but assignments are often self-initiated based on what is necessary to gain desired results.

Comments

  • Some travel is required for team meetings and conferences and is expected to be 10% or less.
  • Position is new, full-time and needed to ASAP.
  • Flexible work location, can be either home or office based, or a combination if living in Austin.
  • CDISC offers an attractive benefit package and competitive compensation.
  • Please send CV, cover letter and salary requirements using this form.