Cures Start Here. At **MEMBERS ONLY**SIGN UP NOW***., home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at **MEMBERS ONLY**SIGN UP NOW***. in Seattle, WA is seeking a highly motivated and effective Senior Manager to lead SCHARP's Data Analytics Unit (DAU) and provide the unit with technical guidance and vision. The DAU is made of approximately 45 biostatisticians and statistical programming employees that work in conjunction with other SCHARP units to manage multiple international clinical trials across all phases including regulatory submission studies. The DAU has responsibility for coordinating the statistical design, reporting, and analysis of clinical trial protocols.
The Senior Manager, Data Analytics Unit (DAU) is a member of SCHARP's Senior Management Team and partners with the SCHARP Director, other unit heads, and the DAU's Statistical Managers to develop department-wide strategy, vision, mission, infrastructure, policies, and standards. The Senior Manager, DAU reports to the SCHARP Director.
The Senior Manager, DAU is responsible for providing overall management of the unit and supervision of statistical managers and senior statistical associates. In addition, he or she oversees resources and priorities to support workflows in the unit and across SCHARP. The Senior Manager, DAU is the strategic and organizational manager responsible for ensuring that the unit is operating effectively and that it meets the requirements of the research studies in a regulatory compliant manner.
Provide strategic, organizational, and operational management and guidance to the Data Analytics Unit.
Collaborate with the other SCHARP Unit Heads to create and implement overall organizational vision and strategic direction.
Foster and promote the long-term development of the Data Analytics Unit, work closely with the SCHARP Director, senior management team, and the DAU's statistical managers to define ways in which the DAU contributes to the advancement of SCHARP and to improve the operational effectiveness of the unit.
Supervise Data Analytics Unit managers.
Develop and maintain staff morale, engagement, and professional development.
Monitor unit deliverables and related resources and timelines including communicating issues regarding conflicts and/or resource limitations.
Monitor project and protocol workflows, capacity, priorities and staffing and represent the interests of the DAU as a member of SCHARP Senior Management Team.
Change Management and Quality Assurance
Lead departmental efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, and ICH guidelines, and that meets regulatory submission requirements, and CDISC standards.
Oversee and ensure quality assurance in coordination with the Quality Management section.
In partnership with SCHARP's Business Support Services unit and the Project Management Steering Committee, prioritize and manage the implementation of SCHARP projects that intersect the DAU such as continuous quality improvement, operational effectiveness, and technical infrastructure improvement projects.
Facilitates adoption of new and forward-thinking practices technologies and tools that improve the efficiency, effectiveness or the regulatory compliance of the unit.
Evaluate and identify efficiencies and process improvements including leading infrastructure and technological upgrades as needed to improve unit intake, workflow, documentation and tracking, and project/protocol management.
PhD or Master's degree in public health, epidemiology, biostatistics or other health related or scientific field
Minimum of 3 years management experience in a clinical research or healthcare organization
Experienced and accomplished mentor, leader and manager
Excellent organizational and communication skills
At least 5 years of experience managing a statistics group in a clinical research organization
Proficiency in analysis and reporting of phase 1- 3 clinical trials
Expertise in clinical trials data analytics and data management in a regulated environment
Working knowledge of 21CFR-11, GCP, ICH, and FDA requirements
Familiarity with CDISC: SDTM and ADaM standards
Organizational change management experience
Experience with strategic and operational planning
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