Senior Director, Clinical Data Standards

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations & 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.

A CCOUNTABILITIES:

• 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 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Massachusetts - Virtual

U.S. Base Salary Range:
$208,200.00 - $327,140.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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