Cures Start Here. At Fred Hutchinson Cancer Research Center, 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 with minimal side effects. 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.
About the Division:
The mission of the Vaccine and Infectious Diseases Division (VIDD) of Fred Hutch is to eliminate or minimize the worldwide impact of globally significant infectious diseases. The Division shares the Center's values of scientific excellence, respect, openness, and innovation in the pursuit of its mission.
About the Department:
Biostatistics, Bioinformatics and Epidemiology in the area of infectious diseases focuses on important questions: Where is the highest concentration of people with infectious disease, such as HIV/AIDS, tuberculosis, malaria, influenza and cholera? What are the risk factors for the population in these parts of the world in developing the disease? How can we work within communities to help change the behavior that presents the most risk? Join VIDD's Population Sciences program faculty and staff by providing integral support of their specialized work in math modeling, epidemiology, and statistics in protocols that are related to the spread and control of infectious diseases.
- The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) provides statistical collaboration to infectious disease researchers around the world and conducts a complementary program of statistical methodology, and mathematical modeling research. SCHARP also collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of infectious disease as a threat to human health. SCHARP is part of the program of Population Sciences within VIDD.
SCHARP provides statistical and data management services to:
- The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and experts testing preventive vaccines against HIV/AIDS
- The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV
- The Microbicides Trials Network (MTN) is collaboration among researchers worldwide who conduct clinical trials using microbial preventions
- The Collaboration for AIDS Vaccine Discovery (CAVD) is an international network of scientists and experts dedicated to designing a variety of novel HIV vaccine candidates and advancing the most promising candidates to clinical trials
SCHARP consists of four units: Data Analytics Unit (DAU), Protocol Management Unit (PMU), Data Management Unit (DMU), and Technology Systems & Services (TSS). The DAU consists of Applied Statistics section for each of the four Networks and a Statistical Programming section. The DAU has responsibility for coordinating the statistical design, reporting and analysis at SCHARP for each clinical trial protocol. SCHARP DAU staff work with protocol managers, data managers, clinical investigators and Fred Hutchinson faculty statisticians and other stakeholders to manage the statistical operations of SCHARP's clinical trials.
SCHARP is seeking a DAU Head who will provide SCHARP and Data Analytic Unit staff with leadership, advocacy, technical guidance, and vision.
The DAU Head provides leadership to the unit, and collaborates with other SCHARP unit heads and the SCHARP Director to develop organizational strategy. This includes developing policies, procedures and methods; oversight of manager and supervisory staff; management of workflow, staffing capacity and prioritization; and collaboration with other groups in SCHARP. The DAU Head reports to the SCHARP Director, works under minimal supervision, communicates effectively with DAU staff and with others in SCHARP, and is responsive to the needs of SCHARP investigators and external collaborators/partners. The DAU Head oversees the the development of and adheres to SCHARP Standard Operating Procedures (SOPs), Work Practice Guidelines (WPGs), applicable clinical trial regulations, and patient confidentiality requirements.
The DAU Head is responsible for leading the statistical research associates and statistical programmers including planning for the long-term development, and stability of the group; representing the group with senior management, faculty, and others within the organization; advocating for the group and encouraging/assisting staff in their professional development; and defining the ways in which the DAU contributes to the advancement of SCHARP.
The DAU Head is responsible for providing management and supervision to the unit. In this role, the DAU Head will monitor workflows, resources and priorities, and will communicate with stakeholders about progress and workload capacity. The DAU Head will be responsible for building and maintain staff morale and engagement, identifying when staffing levels require adjustment, hiring new staff, providing staff with clear guidance and support, providing/obtaining relevant training and professional development, and addressing performance issues.
The DAU Head will be responsible for managing the unit's structure and ensuring it meets the current and future business needs. The DAU Head will be an excellent listener, communicator, mentor and coach to the staff to ensure they receive support as needed.
The DAU Head will possess first-hand experience with clinical research, statistical analysis, and data management. The DAU Head will have an aptitude for learning about current operational activities, and will develop and advocate for adopting advances/efficiencies in these practices (as needed). The DAU Head will be responsible for evaluating processes, providing feedback on best practices, and identifying areas for improvement.
The DAU Head will promote a sense of unity and coherence within SCHARP and the DAU and will foster a high quality and customer focused unit. He or she will provide clear expectations and will be responsive to the needs of managers and staff within the unit.
In support of protocol requirements, statistical analysis plans, funding agency requirements, and organizational needs, the DAU Head may perform some or all of the following tasks:
- Provide leadership, strategic planning and guidance to the DAU including direct supervision of the Statistical Programming Manager and the network Statistical Managers, who directly manage the staff working in their respective sections within the DAU.
- Conduct and facilitate regular team meetings. Conduct regular 1:1 meetings with direct reports.
- Oversee DAU Manager performance and practices relating to hiring, training, time and effort certification approval, performance review, approval of leave requests and disciplinary or termination actions.
- Evaluate and ensure a match between DAU services and the research timelines and available resources including communicating issues regarding conflicts and/or resource limitations to the SCHARP - Senior Management Team.
- Participate as a member of SCHARP's Senior Management Team, contributing to organization-wide strategy, vision, mission, infrastructure evaluation, re-organization. Resource budgeting, evaluation of internal committees and setting organizational policies and standards.
- Work with Investigators and other SCHARP Unit Heads to ensure that the statistical design reporting and analysis needs of the research studies are met and that SCHARP standard operating procedures are maintained.
- In conjunction with the Quality management section, oversee development and implementation of general and unit-specific SCHARP SOPs in conformance with Good Clinical Practices (GCP) and Good - Clinical Data Management Practices (GCDMP).
- Build and manage relationships between the DAU and the other SCHARP Units.
- Communicate with staff on an ongoing basis on all applicable information that enables staff to have a better understanding of the organization.
- Lead infrastructure development efforts as needed. Keep abreast of current trends in protocol management, and propose/enact improvements to the unit and the organization as needed.
- Determine the unit's future technological needs. Make recommendations regarding any technological changes required to support upcoming clinical trials.
- Standardize work practices across studies where practical, and participate in within-group and cross-group standardization efforts.
- Other duties as assigned.
- Doctoral or Master's degree in related field
- Minimum of 5 years of senior management level experience including supervision, resource allocation, project management and strategic planning in a clinical research organization
- Strong background in statistical computing within a clinical trial setting
- Prefer industry experience
- Knowledge of CDISC standards
- Experience participating in strategic planning and/or developing tactics for managing organizational change.
- Excellent oral and written communication skills as well as technical knowledge and leadership skills are essential.
- Must have skills as a highly successful and effective leader and manager; ability to communicate with audiences with varying levels of technical sophistication and understanding