Senior Director, Clinical Data Standards

Role Summary

Senior Director, Clinical Data Standards. Remote role reporting to the Vice President, Clinical Data Operations & Standards.

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.
• Responsible for establishing and managing a Standards vendor to support Standards Management vision.
• Responsible for end-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and the ongoing, thorough 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.
• Participates with and influences at industry standards forums in support of Takeda’s therapeutic areas.
• Serves as a resource to support questions raised by regulatory agencies.

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 (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS.
• Expertise in the requirements and technology required 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. Comprehensive understanding of pharmaceutical standard initiatives such as 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.
• Is comfortable with ambiguity.
• Support a culture of continual improvement and innovation; promote knowledge sharing.

Education

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