Senior Director, Clinical Data Standards

Role Summary

Senior Director, Clinical Data Standards. This role is remote and reports to the Vice President, Clinical Data Operations & Standards. The position leads global data standards strategy, governance, and interoperability across the clinical data continuum, partnering with Clinical Data Strategy & Operations Leaders, TAU Leaders, and vendor/partners to advance standards initiatives and support regulatory expectations.

Responsibilities

• Develop, establish, and drive Takeda’s global data standards, processes, and technologies across the clinical data continuum to ensure quality deliverables and global data interoperability.
• Establish and manage a Standards vendor to support the Standards Management vision.
• Oversee end-to-end Standards Governance to ensure proper utilization, adherence to governance and processes, and ongoing assessment of library enhancements and deviations.
• Build relationships across the global organization and with vendor partners to support the standards vision and implementation.
• Participate with and influence industry standards forums in support of therapeutic areas.
• Serve as a resource to support questions raised by regulatory agencies.
• Has advanced knowledge of all standard library components and metadata across the data collection, analysis, and reporting continuum.
• Develop and adhere to Standards Management vision and metadata management strategy in collaboration with leadership.
• Lead cross-functional Standards initiatives and ensure coherence of standards initiatives across the organization.
• Provide strategic guidance toward execution of the data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives.
• Supervise staff and vendors developing the standards library to ensure alignment to the standards strategy.
• Develop training strategy and ensure a consistent training program for standards.
• Provide senior oversight to vendor/CROs for utilization of Takeda standards.
• Develop metrics to assess standards utilization and development trends; oversee Standards Governance and deviations from standards content and processes.
• Drive ongoing development and improvement of industry standards and engage with external organizations (e.g., CDISC, SCDM, EDC users groups, SAS users groups, Third Party Data Acquisition groups).
• Communicate submission standards, regulatory expectations, and industry trends to the Takeda organization.
• Ensure compliance with applicable regulatory expectations.

Qualifications

• BS/BA or MS in a life science or analytical area.
• 12 years of data management and/or database or statistical programming experience in the pharmaceutical industry or health-related field.
• 8+ years of experience supporting clinical trials across all phases of development.
• 5+ years of progressive management experience.
• Proven track record for development and management of a standards library.
• In-depth knowledge of data management systems and processes, analysis and reporting principles.
• Proficiency in statistical programming languages (e.g., SAS).
• Technical expertise (Windows NT and UNIX) and familiarity with software products used with SAS.
• Expertise in electronic data capture and electronic submissions.
• Proven track record in identifying and implementing organization-wide initiatives, standards, and processes; managing global cross-functional standards and processes.
• Knowledge of medical and statistical terminology; understanding of CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.
• Able to influence without authority.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Entrepreneurial and innovative; willing to take measured risks and challenge the status quo.
• Pragmatic and willing to drive and support change; comfortable with ambiguity.
• Commitment to continual improvement and knowledge sharing.

Education

• BS/BA or MS in a life science or analytical area.