Senior Director, Clinical Data Standards

Role Summary

Senior Director, Clinical Data Standards, remote-based role reporting to the Vice President, Clinical Data Operations & Standards. The role focuses on developing and driving Takeda’s global data standards, processes, and technologies across the clinical data continuum to ensure quality of deliverables and global data interoperability.

Responsibilities

• In collaboration with Clinical Data Strategy & Operations Leaders, TAU Leaders, and other functional area leadership to develop, establish and drive strategy of Takeda’s global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability.
• Establishing and managing a Standards vendor to support Standards Management vision.
• End-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and ongoing assessment of library enhancements and deviations.
• Build relationships across the global Takeda organization and with vendor partners in support of 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.

Qualifications

• Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum.
• Works with Clinical Data Strategy & Operations Leaders, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy.
• Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization.
• Provides strategic guidance toward execution of comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives.
• Supervises staff and vendors developing standards library to ensure alignment to standards strategy.
• Develops training strategy and ensures consistent training program for standards.
• Provides senior oversight to vendor/CROs for utilization of Takeda standards.
• Conducts ongoing review and development of metrics to assess standards utilization and development trends.
• Oversees Standards Governance, managing deviations from standards content and processes.
• Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, Third Party Data Acquisition groups, etc.
• Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization.
• Complies with all applicable regulatory expectations.

Education

• 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.

Skills

• 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 with Windows NT and UNIX operating systems; familiarity with software products and technologies used with SAS.
• Expertise in requirements and technology to support electronic data capture and electronic submissions.
• Proven ability to identify and implement organization-wide initiatives, standards, and processes; experience managing global, cross-functional standards and processes.
• Knowledge of medical and statistical terminology; understanding of CDISC (ADaM, SDTM, CDASH and ODM), HL7, and related pharmaceutical standard initiatives.
• Able to influence without authority; excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Entrepreneurial and innovative; capable of driving change and promoting knowledge sharing.
• Comfort with ambiguity; supports a culture of continual improvement and innovation.

Additional Requirements

• Locations: Massachusetts - Virtual