Senior Director, Clinical Data Standards

Role Summary

Senior Director, Clinical Data Standards. This is a remote role reporting to the Vice President, Clinical Data Operations & Standards. Responsible for leading Takeda’s global data standards strategy, governance, and interoperability across the clinical data continuum, and for managing standards libraries and vendor relationships to support regulatory expectations and industry collaborations.

Responsibilities

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

Qualifications

• BS/BA or MS in a life science or analytical area.
• 12 years data management and/or database or statistical programming experience in 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.
• Good knowledge of statistical programming languages (e.g., SAS).
• Technical expertise (Windows NT and UNIX) and familiarity with software products and technologies used with SAS.
• Expertise in the requirements and technology to support electronic data capture and electronic submissions.
• Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.
• Proven track record in 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; takes measured risks; thinks outside the box; challenges the status quo.
• Pragmatic and willing to drive and support change.
• Comfortable with ambiguity; supports a culture of continual improvement and knowledge sharing.

Education

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