Executive Director, Data Management and Standards (BOSTON)
Takeda Pharmaceutical, Boston, MA, United States
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. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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. 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. Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation. 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. Develops training strategy and ensures consistent training program for standards. 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. 12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field. ~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). ~ 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 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.) ~ takes measured risks; Massachusetts - Virtual The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
S. based employees may be eligible for short-term and/ or long-term incentives. 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. 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.
Massachusetts - Virtual Full time LI-Remote
Privacy Notice
and
Terms of Use
. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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. 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. Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation. 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. Develops training strategy and ensures consistent training program for standards. 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. 12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field. ~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). ~ 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 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.) ~ takes measured risks; Massachusetts - Virtual The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
S. based employees may be eligible for short-term and/ or long-term incentives. 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. 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.
Massachusetts - Virtual Full time LI-Remote