Takeda · 20 hours ago
Senior Director, Clinical Data Standards
United States
Full-time
Remote
Director/Executive
$208K/yr - $327K/yr
12+ years expTakeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry. They are seeking a Senior Director, Clinical Data Standards who will be responsible for developing and driving the strategy of global data standards and processes across the clinical data continuum, ensuring quality deliverables and data interoperability.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
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
Qualification
Required
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
Benefits
Medical, dental, vision insurance
A 401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
A tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-09
2026-01-08
Company data provided by crunchbase