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. 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.
Clinical Biostatistics collaborates with Clinical Research Division (CRD) researchers as the statistical members of the team, whose responsibility is to ensure the highest quality statistical methodology and presentation of data is carried out in the research conducted. Additionally, faculty partner with researchers in Public Health Sciences (PHS), Vaccine and Infectious Disease (VIDD), the University of Washington (UW), Seattle Children's and other national and international researchers. Clinical Biostatistics is a key component of many high profile research projects that are carried out at Fred Hutch. Types of projects include design and analysis of Phase I and II clinical trials, survival analysis, and retrospective studies, among others. Areas of research include hematopoietic cell transplantation (HCT), rheumatology, breast cancer, ovarian cancer, lung cancer, sarcoma, lymphoma, graft-versus-host disease, long-term outcomes, immune function, infectious diseases, and various projects in Basic Sciences and Human Biology.
Clinical Research Data Systems (CRDS) offers technical and statistical support for CRD investigators and their staff, including secure systems for data entry and protocol tracking, as well as on-line questionnaires and database support. CRDS houses and maintains the Gateway database of transplant patients, partnering with Data Abstraction and Center IT (CIT) programmer/analysts.
Data Abstraction is comprised of two groups. The Data Management team works closely with CRDS maintaining CRD databases for all transplant research which are used by CRD investigators, their staff and SCCA staff. They are also responsible for scanning patient charts and related documents into the Optical Web Library (OWL) which allows investigators to access secure patient data from their office. The Data Management team manages the census for SCCA, protocol consents, GVHD grading, multi-center trials and the specimen repository. The CIBMTR/NMDP team is solely responsible for ensuring Fred Hutch/SCCA meet the federal mandate and requirements of being a Comprehensive Cancer Center. They submit reports to CIBMTR/NMDP for transplant patients working closely with Long Term Follow Up (LTFU). CIBMTR/NMDP staff also manage Continuous Process Improvement (CPI), audits (internal and external) and data checks.
The incumbent is responsible for managing all financial, administrative and operational activities of the Clinical Biostatistics unit, Clinical Research Division. This position is the primary point-of-contact for all research engagements, all faculty, CRDS and Data Abstraction in support of the overall mission of the Center.
May perform some or all of the following responsibilities:
- Co-lead strategic planning and business operations design with Director.
- Manage program staff, overseeing hiring, training, performance evaluations, disciplinary action, and layoff/termination issues.
- Supervise program administrative support staff and act independently and on behalf of Director or at his discretion.
- Oversee all program faculty recruitment, acting as liaison between search committees and applicants, and manage administrative responsibilities including travel arrangement, interview scheduling, correspondence, and Center resources.
- Ensure that the program complies with established regulations such as IRB regulations, grant and contract regulations, and Center policies and procedures.
- Manage all grant and contract pre-award/renewal/post-award, investigating potential sources of funding, coordinating the submission of all materials for initial grant/contract applications, monitoring existing grants/contracts, and preparing yearly grant/contract close-out documentation and progress reports. Collaborate with external partners (UW, SCRI, etc.) for subawards to Clinical Biostatistics faculty.
- Manage contracts for equipment and hardware maintenance for CRD servers. Manage annual software license agreements for CRD databases supporting research and clinical trials.
- Develop and monitor the program sponsored and non-sponsored budgets, ensuring the appropriate allocation of funds according to grant/contract guidelines and regulations. Direct and negotiate annual Transfer Price Agreements with SCCA.
- Serve as lead program liaison, interacting with a variety of Center departments, maintaining ongoing communication with affiliated programs and institutions, and representing the program to outside organizations.
- Review, approve, and generate invoices for program expenditures, including but not limited to, purchase requisitions for office supplies/equipment, hardware and software contracts, incoming subawards, Principle Investigator and administrative ProCard expenditures, time reporting, effort certification, and travel.
- Monitor and forecast program resources such as space, equipment, and personnel, ensuring that current program resource needs are met and future program resource needs are anticipated.
- Serve as administrator for the Biostatistical Shared Resource (BSR) and its Advisory Committee, managing budget and assisting with allocating effort to Statistical Research Associates, scheduling and organizing meetings and working with faculty on plans and policies for the BSR.
- Develop and implement program administrative policies, ensuring consistency in operating procedures across studies or projects.
- Provide mentoring and engage staff for updating and maintaining CVs, biosketches, other support, publications, program websites, directories and records storage for the program Principal Investigators.
- Perform other responsibilities as required.
- Perform other responsibilities as required.Requires BA/BS, Master's degree desirable.
- Minimum of 8+ years related program management or related experience.
- Strong oral and written communication skills.
- Experience with grants, contracts, various agreements and/or other fiscal arrangements, along with strong budgetary skills, tracking are required.
- A strong demonstrated ability to manage complex abilities in a research program and scientific environment/setting desirable.
- External experience related to various partnerships and collaborations is also desirable.
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