SCHARP Career Opportunities

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The only National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion. 

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking an Application Support Specialist I-II.

The Application Support Specialist works as part of a team to ensure the proper functioning of critical applications within SCHARP by actively diagnosing and resolving end user help requests and monitoring the application within the system development life cycle and implementing system changes accordingly.

Responsibilities

Level I

• Monitor technical support issue queues and respond to requests in a timely manner.
• Manage user accounts and permissions for systems in accordance with Standard Operating Procedures.
• Proactively manage data structures (such as folder hierarchies, metadata, content) within applications to ensure they remain timely and accurate.
• Report feature requests and software issues to system owners.
• Work collaboratively with other departments within SCHARP to ensure secure and accurate use of applications.
• Ensure that production processes are functioning efficiently and effectively.
• Participate in the ongoing development and maintenance of Standard Operating Procedures (SOP).
• Perform regression testing of applications as part of an upgrade or as part of a computer system validation team.
• Participate on computer system validation teams as a technical or system owner.

Level II

• All level I responsibilities
• Work with SCHARP’s Information Technology group evaluating and recommending infrastructure needs concordant with current and future application usage.
• Research, recommend, and implement application monitoring for speed, accessibility, and user activity trends.
• Report feature requests and software issues to system owners. Propose and implement system improvements based on feedback gathered from internal and external users.
• Fine-tune content and tools based on feedback from users.

Qualifications

Minimum Qualifications

• Level I: At least one year experience triaging IT support issues.
• Level II: At least three years of experience providing enterprise application support to end users.
• Knowledge of data architecture principles.
• Experience in computer system monitoring, reporting, and usability.
• Thorough and comfortable with following documentation, testing, and QA processes.
• Excellent problem solving, troubleshooting, organization, time management and communication skills.
• Ability to meet deadlines.
• Demonstrated ability to work independently and as part of a team.
• Customer service experience and excellent verbal and written technical communication skills.

Preferred Qualifications

• Experience working in a regulated environment.
• Experience writing standard operating procedures and work instructions.
• Level II:  Experience managing or coordinating small technical projects.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

 The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. Within SCHARP, the Vaccine Immunology Statistical Center (VISC) partners with world-class research programs and immunological laboratories to tackle global public health initiatives in infectious disease. VISC operates within two global research networks: the Collaboration for AIDS Vaccine Discovery (CAVD) and the Global Health Vaccine Accelerator Platforms (GH-VAP), both supported by the Bill and Melinda Gates Foundation.

VISC is seeking a Biostatistician II-III. Biostatisticians provide statistical support across a breadth of applications including pre-clinical and clinical trials of novel vaccines and passive immunization regimens, as well as infectious disease observational studies. We work with high-dimensional single-cell, next generation sequencing, and multiplex immunoassay data, with the overarching goal of improving our understanding of the immune system and correlates of protection provided by vaccines. Our methodological focus ranges from traditional biostatistics, to ML/AI, and dynamic modeling.  We are particularly interested in candidates who are curious and willing to learn, passionate about science and improving global health, and who are excited to be part of a collaborative multidisciplinary team that supports professional growth and personal well-being. We value scientific rigor, open science, inclusion and diversity.

Responsibilities

The Statistical Research Associate provides statistical support in the planning, operations, monitoring, analytic, and exploratory stages of clinical trials and research. Job duties may include some or all of the following:

• Collaborate with PhD biostatisticians and computational biologists, statistical research associates and statistical programmers, data scientists, project managers, laboratory scientists, clinicians, and other subject-matter experts to provide statistical support for immunological assay analyses from preclinical, clinical, and observational studies.
• Identify statistical and computational methods to properly address scientific questions.
• Generate professional and reproducible reports for distribution to external clients.
• Participate in analysis data specifications, code and/or writing review, and verification of reports prepared by programmers, statisticians, or other team members.
• Contribute to and review study documents including protocol drafts, statistical analysis plans, scientific abstracts and manuscripts, and other documents as required.
• Participate in internal, study team, organizational, and scientific meetings.
• Participate in internal project initiatives to develop new tools and processes, evaluate new statistical software packages, or explore other solutions for improving workflows and team collaboration.
• Represent VISC and SCHARP at professional meetings.
• Mentor more junior SRAs as required.

Qualifications

Minimum qualifications

• MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience
• Level II: A minimum of 1 year of related work experience is required.
• Level III: A minimum of 3 years of related work experience is required.
• Demonstrated knowledge of general statistical practice within clinical trials.
• Thorough understanding of statistical programming process and best practices.
• Proficiency with the SAS or R (as required by specific team/project)
• Functional understanding of GCP and regulatory requirements
• Proven track record of collaboration with internal colleagues
• Strong oral and written communication skills

Preferred Qualifications

Level II

• 2+ years of related work experience
• Experience with laboratory assay data.
• Interest or demonstrated experience in pharmacokinetics or mathematical modeling
• Experience with R-markdown.
• Experience with Git, GitHub, or other version control software.
• Demonstrated specialized knowledge of statistical practice for laboratory assay data
• Functional understanding of statistical programming process and best practices
• Strong organizational and multi-tasking skills
• Proven track record of collaboration with external collaborators

Level III

• 4+ years of relevant work experience
• Experience with laboratory assay data.
• Interest or demonstrated experience in pharmacokinetics or mathematical modeling
• Experience with R-markdown.
• Experience with Git, GitHub, or other version control software.
• Demonstrated specialized knowledge of statistical practice for laboratory assay data
• Functional understanding of statistical programming process and best practices
• Strong organizational and multi-tasking skills
• Proven track record of collaboration with external collaborators

VISC-specific preferences

• Experience with laboratory assay data.
• Experience with R-markdown.
• Experience with Git, GitHub, or other version control software.
   
   

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The only National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.  

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Business Intelligence Analyst, Supervisor.

The Business Intelligence Analyst (BIA) Supervisor will directly supervise junior analysts by providing mentorship and management of the team. The BIA Supervisor will manage team's work allocation and prioritization, monitor deliverables, and work with their supervisor to manage resources and priorities. The BIA Supervisor will define team's best practices and standard procedures, and ensure their adoption across the team.  The BIA Supervisor effectively coordinates with internal and external stakeholders to define requirements and leverage their expertise of business and data analysis and technical skills to develop insightful, reusable, and easily maintainable operational reports and dashboards. Core to the role is the ability to lead staff, communicate effectively, be a subject-matter and technical expert, be highly collaborative and responsive to the needs of customers within an environment of mutual cooperation and respect. The BIA Supervisor is a critical thinker and a leader who can create team’s strategic vision in alignment with organizations strategic vision, and influence development of policies, procedures, and standard practices.

Responsibilities

• Supervise and mentor junior Business Intelligence Analysts as assigned
• Assist in recruiting and training new team employees
• Conduct performance reviews of direct reports
• Independently prioritize work intake by understanding severity, assessing value, and estimating the effort needed to finish the task
• Lead the Business Intelligence Analysts team to help define process and best practices for gathering requirements, and developing, testing and maintaining clinical trial operations reports and dashboards
• Apply deep analytical skills to translate user and business needs into actionable, creative, and insightful dashboards with high attention to detail, accuracy, and timeliness using SCHARP’s preapproved
• Business Intelligence tools and processes
• Partner with cross-functional teams to evaluate existing reporting and provide more in-depth, precise analytics to better serve network partners and stakeholders
• Perform data mining and proactive analysis which helps stakeholders to have data-driven insights to study data
• Develop standardized code libraries that can be reused to gain operational efficiencies
• Apply best practices throughout the software development life cycle (SDLC)
• Respond to implementation issues and troubleshoot user problems by diving deep into data or visualizations
• Perform peer review of reports and datasets built by other programmers
• Support development of new or updated work instructions and standardized operating procedures and processes
• Engage with data and technology teams to ensure business needs are adequately met through appropriate technology solutions
• Encourage team partnership and promote enthusiasm; Ability to influence and collaborate across various functional groups
• Oversee team process improvement projects
• Ensure quality and adherence to standard procedures in the work and operations of direct reports and other team members. Oversee timely completion of QA documentation and training within team
• Foster and promote the long-term development of the team by cultivating an environment of continuous learning and by discussing new feature updates in BI tools technology and developing new
• analytical approaches in accordance with industry 
• May include up Tableau Server Site Administrator responsibilities such as:
  • Fulfil the role of System Owner of Tableau Server application in SCHARP to ensure the application is 21 CFR Part 11 compliant
  • Create and manage site user groups, permissions, and content structure
  • Monitor site content, traffic, and performance and report out to data governance committee on a regular basis

Qualifications

Minimum Qualifications:

• Bachelor’s degree in statistics or computer science or a scientific, technical, or health-related field, OR a combination of commensurate education and work experience
• 5+ years of experience as a business analyst or related experience (e.g., data analytics) with 3+ years’ experience with Business intelligence tools and techniques (Data Integration, Reporting, Data Mining, Data Visualizations, Dashboarding, ETL, drilldowns)
• 5+ years’ experience developing reports using an enterprise reporting tool such as Business Objects, Tableau, Power BI, or SQL Server Reporting Services with at least 1 year of experience with SQL, SAS, Python, R or Perl on a PC/Unix platform.
• At least 1 year or experience mentoring, leading or with direct supervision
• Working knowledge of Medidata Rave EDC (or equivalent experience with other EDC system)
• Experience working through the entire SDLC
• Knowledge of an issue tracking tool such as JIRA
• Working knowledge of relational database management system
• Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
• Demonstrated ability to multi-task and appropriately prioritize work assignments.
• Knowledge of good clinical data management practices in health research

Preferred Qualifications:

• Master’s degree in statistics or computer science or a scientific, technical, or health-related field
• Experience working in a biomedical laboratory and/or experience with clinical trials and data management
• Knowledge of and experience in programming for scientific research
• Experience in good clinical data management practices in health research
• Experience in drafting and maintaining controlled documents
• Knowledge of CDISC standards such as CDASH and SDTM
• Previous experience implementing data governance best practices within an organization or team
• Experience working as Tableau Server system and/or site administrator
• Tableau Certification or other BI tool certification

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Data Architect.

The Data Architect is responsible for designing and managing the enterprise data architecture for SCHARP.  The Data Architect will be primarily responsible for collaborating with stakeholders to translate business and study requirements for data analysis and reporting into data-centric solutions and working with business colleagues, system developers and analysts to ensure the performance, quality assurance, security, and integrity of the SCHARP data warehouse and reporting systems. The Data Architect also provides technical leadership in the implementation of data systems, data integrations, and data management solutions within SCHARP's data ecosystem. 

Responsibilities

May include some or all of the following:

• Partner with key stakeholders, data owners, and data governance team members to lead the evolution of SCHARP’s data management capabilities by aligning the future state enterprise information architecture with SCHARP’s data strategy and road-map
• Collaborate with data owners, dataset developers, data governance, and software development teams to design and implement data management solutions
• Maintain appropriate data architecture, data modeling, and reporting capability of enterprise data to data warehouses, data marts, and report marts
• Develop data models using best practices within various data management systems to optimize reporting and analysis
• Design, document, and maintain logical data models including data definitions and data standards
• Design data warehouse/integrated data hub sourcing strategies and provide design oversight to road-map implementation projects
• Architect data solutions to meet business needs, ensuring technical viability of new projects and successful deployments
• Collaborate and plan project tasks within an agile development environment
• Maintain appropriate documentation of data architecture, data modeling, source to target mappings, ETL processes, and reporting requirements
• Collaborate with meta-data management and data owners to manage data lineage traceability from source to consumption and where-used patterns across system landscape and electronic file system
• Work with data governance and security leads to create data classification definitions and standards and provide impact analysis of regulatory or statutory requirements using lineage
• Align with SCHARP’s analysis and reporting leads to support publication and consumption of SCHARP’s reporting and analytics requirements
• Assist data governance and /or data security leads with any inquiries related to data access and work with data analytics and reporting teams to provide requirements for impact analysis reports where appropriate
• Apply and adhere to CDISC data standards and guidelines where applicable
• Ensure all data solutions exhibit high levels of performance, security, governance, privacy, scalability, maintainability, and appropriate re-usability and reliability upon deployment

Qualifications

Minimum Qualifications

• Bachelor’s degree or a combination of commensurate education and work experience
• At least 8 years’ experience in data curation, management, or analysis
• Experience developing data architecture solutions
• Extensive knowledge of database platforms and data management methods, systems, and tools e.g., as outlined in DAMA DMBOK2
• Knowledge and familiarity with relational database management systems (RDBMS), data warehousing, dimensional modeling, and/or business intelligence concepts
• Strong vision for how data can inform business strategy
• Help develop and maintain security architecture standards, patterns & guidelines
• Ability to work and communicate effectively in matrixed environments and to build and sustain collaborative working across business and IT roles
• Ability to set goals work independently and to work with and manage multiple stakeholders' expectations and priorities

Preferred Qualifications

• Master’s degree in computer science or a scientific, or technical field
• IT/Architecture certification e.g., CBIP, CDMP, TOGAF
• Functional knowledge of data domains and processes within the Clinical Data Lifecycle
• Previous experience implementing data governance and/or data security best practices within an organization or team
• Familiarity with CDISC data standards (CDASH, SDTM, ADaM, and controlled terminology references)
• Leadership experience

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Dataset Developer I-II.

The Dataset Developer is responsible for the development of protocol and enterprise level standard datasets in SCHARP’s clinical data warehouse, systems works to ensure that SCHARP’s clinical data repository, data mart and report mart systems. SCHARP Dataset Developers use extract, transform, and load (ETL) and other data management processes and tools to develop datasets to support Programming, Analytics, and Reporting team requirements.

Responsibilities

May include some or all of the following:

Level I

• Implement document, and maintain, under limited supervision, enterprise-wide and study-specific derived datasets in SCHARP’s data warehouse using configurable transformation and other languages. Collaborate with data standards analysts, programmers, data architects, reports analysts, statisticians and the data governance and data security team in the development and documentation of standard datasets used for reporting and analysis.
• Apply and adhere to CDISC data standards and guidelines where required in the production of reporting datasets and interpret and implement (SDTM) dataset specifications provided by data standards analysts or data services team members.
• Implement and provision reporting datasets to report analysts, programmers and statisticians for use in a Report Mart.
• Perform data cuts, data freezes, and study snapshots in SCHARP’s data warehouse using Python.
• Collaborate with SCHARP software developers to report defects and suggest improvements to the data warehouse and associated systems.
• Set up, test and maintain version control of standard datasets in the central data warehouse system.
• Follow standard practices for implementing or modifying derived datasets.
• Collaborate with the data standards and data governance teams on naming and standardizing data objects (schemas, datasets) in the data warehouse.
• Perform other duties as required.

Level II

• All level I responsibilities.
• Independently implement and oversee enterprise-wide and study-specific derived datasets in SCHARP’s data warehouse using configurable transformation and other languages.
• Oversee and perform data cuts, data freezes, and study snapshots in SCHARP’s data warehouse using Python.
• Develop and document standard practices for implementing or modifying derived datasets to be used by all dataset developers.
• Oversee the curation of schemas, snapshots, and initial data permissions in the data warehouse.
• Contribute to development and editing of applicable work instructions and standard operating procedures.
• Lead and/or supervise more junior dataset developers as necessary.

Qualifications

Minimum Qualifications

• Bachelor’s degree in computer science, or a scientific, technical, or health-related field, or a combination of commensurate education and work experience.
• • Level I:
    • At least 2 years of experience building and maintaining datasets, tables, or views within a database.
    • Basic knowledge of relational databases including tables, views, data types, and keys.
  • Level II: 
    • At least 5 years of experience building and maintaining datasets, tables, or views within a database.At least 2 years of experience working in an Extract-Load-Transform (ELT/ETL) system such as SQL Server Integration Services (SSIS), WhereScape Red, Talend, or Pentaho.
    • Strong knowledge of relational databases including tables, views, data types, and keys.
    • Knowledge of CDISC data standards, specifically SDTM.
• Basic knowledge of relational databases including tables, views, data types, and keys.
• Experience using a programming or scripting language such as Python.
• Experience querying databases using a query language such as SQL.
• Experience with declaritive operations such as writing data transformations such as filters, merges, and maps.
• Experience using a version control system such as Subversion.
• Ability to read and comprehend specifications.
• Excellent verbal and written communication skills.
• Demonstrated ability to work independently and as part of a team.

Preferred Qualifications

• Master’s degree in computer science or a scientific, technical, or health-related field.
• • Level I:
    • Experience SQL Server Integration Services (SSIS), WhereScape Red, Talend, or Pentaho.
    • Experience implementing CDISC data standards, specifically SDTM.
  • Level II: 
    • Experience working with Software Development Life Cycle methods.

• Experience with an expression language such as JEXL.
• Experience with data interchange formats such as XML and JSON.
• Experience with good clinical data management practices in health research.
• Experience working in a regulated environment.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

The Statistical Center for HIVAIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center primarily focused on HIV prevention research. SCHARP has an annual budget of over $50 million, more than 190 employees, and is currently managing over 40 active phase I – III clinical trials in over 200 clinical sites around the world. SCHARP is seeking a Director of the Data Services and Governance team.  The Director of Data Services and Governance is responsible for leading and delivering a commitment to improving the integrity, value, and usability of SCHARP’s critical data assets through better governance, security, and enterprise architecture of its data. The Data Services and Governance Director provides overall leadership and management of the data services group and is a member of SCHARP’s senior management team. In this leadership role, the Data Services and Governance Director partners with the SCHARP Executive Director, the Senior Management Team, and other managers, subject matter experts, and stakeholders to develop department-wide strategy, vision, mission, infrastructure, policies, and standards.

Responsibilities

• Provide strategic direction for governance of SCHARP’s critical data assets to support both business and technical direction and operational management of the Data Services Unit.
• Coordinate the production of a Data Governance Roadmap and steer its implementation.
• Oversee ongoing adherence and compliance and security of SCHARP’s critical data assets.
• Collaborate with the other SCHARP Directors to create and implement overall organizational vision and strategic direction.
• Provide technical vision and guidance on the development of infrastructure needed to support and maintain data governance for regulated Phase I/II/III clinical trials and the various R&D/pre-clinical studies. 
• Oversee the development and maintenance of data security architecture standards, processes, and guidelines.
• Serve as the data governance subject matter expert and liaison with research partners, sponsors funders, regulators, and 3rd party vendors.
• Lead departmental efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, GDRP, HIPAA and ICH guidelines, and that meets regulatory submission requirements, and CDISC standards, where applicable.
• Foster and promote SCHARP initiatives and support of DEI and an Irresistible Organization.
• Provide training, direction, and performance management for individual employees; manage workloads and priorities, support professional development, work withFred Hutch Human Resources staff to facilitate recruiting efforts and staffing changes.
• Provide organizational leadership, support collaboration and team building, facilitate cross-group interactions and projects, and identify infrastructure and technological needs.
• Evaluate and identify efficiencies and process improvements including leading infrastructure and technological upgrades as needed to improve the governance, security, and access to SCHARP data assets.
• Oversee the strategy, policies, and SOPs related to data retention, data security, data access and data sharing that align with regulatory and industry requirements.
• Collaborate with stakeholders to identify KPIs related to data governance and monitor performance against the KPIs.
• Represent the interests of the Data Services as a member of SCHARP Senior Management Team.

Qualifications

Minimum Qualifications

• Master’s degree in Science, Public Health, or similar degree in a scientific, technical, or health-related field with 10+ years of experience in data management, governance, security or related disciplines or equivalent combination of experience and education.
• At least 5 years of experience in direct staff supervision/management.
• Extensive leadership experience with expertise in Data Governance
• Knowledge of current IT risks and experience implementing security solutions
• Knowledge of clinical research business and regulatory requirements.
• Ability to work in matrixed environments and to build and sustain collaborative relationships across business and IT roles
• Ability to effectively monitor industry and regulatory activities and assess impact on Data
   

Preferred Qualifications

• Extensive experience and knowledge of human clinical research trials, clinical research industry best practices and regulations.
• Familiarity with CDISC data standards (CDASH, SDTM, ADaM, and controlled terminology references)
• Familiarity with GCP, GLP, GCDMP, and CDISC standards.
• In depth knowledge of clinical trials and data security and privacy regulations (e.g., HIPAA, GDPR, FISMA, ICH and 21 CFR-Part 11, etc.)
   

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Research Associate level II-III.

Responsibilities

The Statistical Research Associate provides statistical support in the planning, operations, monitoring, analytic, and exploratory stages of clinical trials and research. Job duties may include some or all of the following:

• Collaborate with PhD statisticians/epidemiologists, SRAs, laboratory scientists, laboratory data managers, and other subject-matter experts to provide statistical support for clinical studies and research projects or laboratory data and analyses including statistical considerations and planning (power and sample size calculations), randomization lists, consultation, study data analyses, and written summaries and tables of results for use in study reports - for example, Data and Safety Monitoring Boards or other interim review meetings, scientific abstracts and manuscripts, and/or tables in support of a Clinical Study Report for submission
• Contribute to and review study documents including protocol drafts, statistical analysis plans, case report forms, and other documents as required
• Collaborate with data management and operations in the development of quality assurance procedures for on-going data collection, cleaning and analysis - such as establishing edit checks, or HIV endpoint verification
• Participate in verification of standard reports prepared by programmers or other team members
• Apply and adhere to CDISC data standards and guidelines where required in the production of analysis datasets and reports; assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides)
• Generate written summaries for use in customized statistical lab reports
• Participate in protocol team conference calls and meetings, organizational meetings, interim data review meetings, scientific meetings, regional meetings and internal team meetings as required
• Maintain functional understanding of standard policies and procedures and complete required training in a timely manner; Contribute to the development and maintenance of standard procedures and related quality documents
• Participate in internal project initiatives which may include developing new tools and processes, evaluating new statistical software packages, or exploring other value-added team activities
• Represent SCHARP and the data analytics unit at professional meetings
• Mentor junior SRAs as required
• Perform other responsibilities as required

Qualifications

Minimum qualifications

• MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience
• • Level II:A minimum of 1 year of related work experience is required
  • Level III: A minimum of 3 years of related work experience is required
• Proficiency with the SAS or R (as required by specific team/project)
• Functional understanding of GCP and regulatory requirements
• Proven track record of collaboration with internal colleagues
• Strong oral and written communication skills

Preferred Qualifications
 
Level II

• 2+ years of related work experience
• Demonstrated elementary knowledge of statistical practice within clinical trials
• Functional understanding of statistical programming process and best practices

Level III

• 4+ years of relevant work experience
• Demonstrated specialized knowledge of statistical practice within network specialization
• Proven track record of collaboration with external collaborators

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.  #ZR

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.  

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Systems/Database Administrator I.

The Systems/Database Administrator is expected to ensure the stability, integrity, and efficient operation of infrastructure and database systems that support SCHARP, such as servers, storage, and organization-specific data management and analytic systems. They provide direct support of PostgreSQL – the primary relational database system used in SCHARP and ensure that systems maintain optimal uptime and performance through the use of system monitoring. The Systems/Database Administrator reports to the SCHARP Infrastructure Manager.

This role will have the opportunity to work partially at our Seattle, Washington campus and remotely.

Responsibilities

• Fulfill day-to-day operational tasks associated with maintaining infrastructure and database systems.
• Respond to incidents and service outages to restore service interruptions in a timely manner. Fulfill service requests in the most supportable and expedient way.
• Provide Tier 2 Support of infrastructure and database systems. Act as an escalation point for technical issues as required.
• Monitor and report on infrastructure and database systems’ usage, capacity and availability. Set appropriate monitoring and alerting levels for systems.
• Create new and maintain current and accurate technical documentation and diagrams. Develop standard operating procedures and work instructions.
• Ensure that systems are backed up and have a reliable recovery procedure. Perform restore and disaster recovery tests.
• Provide support for infrastructure and PostgreSQL systems including access control, performance monitoring and tuning, failovers and upgrades.
• Write and debug scripts to aid in systems and database administration and management.
• Analyze the need for third party/off-the-shelf products to be used in systems and database administration, usage and data management. Research and recommend products. Integrate or customize products as necessary.

Qualifications

Minimum Qualifications

• Two years of experience administering infrastructure and/or database systems in an enterprise with increasing responsibilities.
• Experience with Linux server distribution(s); experience authenticating to AD/LDAP.
• Proven expertise with SQL and at least one modern programming language.
• Ability to work independently and drive projects without significant supervision.
• Self-motivated learner.
• Effective communication skills and the ability to work with people with variable technical skills.
• Good organizational skills and the ability to prioritize daily tasks and projects.
• Knowledge of current software and internet standards including DHCP, DNS, LDAP, SMTP, SNMP, SSL/TLS and SSH.
• Experience with current technologies for automating/abstracting infrastructure using available tools or scripting (e.g., Chef, python, bash, ruby).
• Strong multi-faceted, analytical troubleshooting and problem-solving skills.
• Ability to interact successfully and communicate clearly. Able to exercise a high degree of discretion and judgment.
• Reliable contributor both individually and as a member of the team.
• Ability to effectively prioritize work, juggling daily support responsibilities with project driven tasks.

Preferred Qualifications

• Bachelor’s degree in Computer Science, Computer Information Systems, Informatics or related field, or equivalent experience
• Experience with server, container, storage and network virtualization technologies such as Xen, Kubernetes, NetApp and F5 desired.
• Experience working in a regulated environment.
• ITIL experience or certification.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.