Senior Director, Clinical Data Standards

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• In collaboration with the Clinical Data Strategy & Operations Leaders, and TAU Leaders, and other functional area leadership to develop, establishes and drives 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.

ACCOUNTABILITIES:

• 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.

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EDUCATION AND EXPERIENCE:

• 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.