Senior Director, Clinical Data Standards

Job not on LinkedIn

November 4

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $208.2k - $327.1k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• In collaboration with the Clinical Data Strategy & Operations Leaders, develop, establish and drive 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. • Participate with and influence at industry standards forums in support of Takeda’s therapeutic areas. • Serve as a resource to support questions raised by regulatory agencies.

🎯 Requirements

• 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

• 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.