Director, Clinical Data Standards
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as the Director, Clinical Data Standards. This role is accountable for the development, maintenance, and strategy of the Sage’s global clinical data standards. This role will report to the Head of Biostatistics or Data Sciences.
In collaboration with the Data Science Leadership Team, establishes and drives strategy of Sage’s global data standards, processes, and technologies across the clinical data continuum for quality of deliverables and global data interoperability. Provides Data Standards leadership and expertise to Sage Data Science and Clinical Operations staff. 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 Sage organization and with Data Science Clinical Service Providers (CSP) in support of the standards implementation.
Roles and Responsibilities
Responsible for the overall development and strategy of Sage’s Global Data Standards.
Responsible for collaboration with the Data Science Leadership Team, Clinical Development Team, and other functional representatives to develop and maintain Sage’s global data standards.
Responsible for development and maintenance Sage’s Data Standards as well as the procedural documents and charters relating to global data standards.
Responsible for broad communication of Sage’s global data standards in a way that minimizes data transformations between systems and functions.
Responsible for Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations.
Leads cross-functional Standards initiatives internal or external to Sage and helps to ensure coherence of standards initiatives across organization.
Develops training strategy and ensures consistent training program for standards
Conducts periodic review and development of metrics to assess standards utilization and development trends
Serves as a resource of Clinical Data Standards to support questions raised by Study Team Members and other stakeholders within the Clinical Development organization. Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Sage organization.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
BA/BS, preferably in the scientific/health care field.
At least 8 years in Data Standards in the pharmaceutical/biotechnology industry with additional 3 plus years of equivalent experience in Data Management, Statistical Programming or Biostatistics in the pharmaceutical/biotechnology industry.
Excellent experience working in cross-functional team-oriented environments
Proven track record for development and management of a standards library
Possesses strong written and verbal communication skills.
Understanding of ICH and regulatory environment as it pertains to data
Knowledge of medical and statistical terminology. Comprehensive understanding and ability to stay abreast of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), etc.
Possesses an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR Part 11 and their application to data standards.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and service providers.
Experience in CNS/Neurology is preferred and experience with orphan indications will be favorably considered.
Understands the scope and focus of clinical studies in phases I-IV and has a proven ability to perform the tasks, manage service provider resources and timelines.
Strong team player that has a positive customer service approach and is solution oriented.
Knowledge of and experience with MedDRA and WHO Drug data dictionaries.
Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
Proven experience in internal and external inspection activities preferred.
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of Sage.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.