Associate Director, Clinical Data Standards
2 weeks ago
Join a Legacy of Innovation 110 Years and Counting
Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.
Summary
The Associate Director, Clinical Data Standards, is responsible for the development, maintenance, and enforcement of data standards through extensive collaborations with Daiichi Sankyo's internal and external stakeholders. Proven experiences in Oncology Therapeutic area with Medical / Scientific acumen in Solid and Liquid tumors, understanding of the CDISC (SDTM, ODM.XML, CDASH) industry standards, Metadata management and Data Mappings and are some of the key requirements of this role.
This role also requires leadership for the continued development and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and being influential in reaching prompt decision making to support DS Program developments. This position provides expertise within the Biostatistics and Data Management teams by having the Medical / Scientific knowledge for designing of CRFs, efficient Data Collection methods, Codelist / Dictionary Managements including Non-CRF Data Mappings (ex: External Data) for data submissions and relative processes.
Working knowledge of early and late-stage submissions per local/regulatory requirements, demonstrated ability to self-start, be solution-oriented with an innovative spirit, and be accountable for results by working in a fast-paced environment are some of the requirements of this role. In addition, significant experiences in the use of data management systems (EDC, MDR, CDR), knowledge of data management processes, tools, methodologies, and scientific know how for overall data collection strategy is a must for the sustainability of the Daiichi Sankyo R&D pipeline.
Responsibilities
- Leadership, Direction, and Strategy:
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