Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Clinical Data Standards in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Clinical Data Technology team, you will be empowered to collaborate with Takeda leaders and oversee Takeda standards, processes and procedures, and a typical day will include:
- In collaboration with the Clinical Data Solutions Leadership Team, and TAU Leaders, 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 Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations.
- Builds relationships across the global Takeda organization and with CRO 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 Solutions Leadership Team, 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 a 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 periodic 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, etc
- Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization
- Complies with all applicable regulatory requirements and Takeda standards and procedures
EDUCATION, EXPERIENCE AND SKILLS:
- 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 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; challenge 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
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.