Lead Data Standards Analyst

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, COVID-19 vaccine development, and preventative methods for other infectious diseases. SCHARP provides operational support to the Vaccine & Immunology Statistical Center (VISC), and other networks situated within the Biostatistics, Bioinformatics, and Epidemiology program of the Vaccine & Infectious Disease Division at Fred Hutch. 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 150 clinical sites around the world. SCHARP is seeking a Lead Data Standards Analyst.

Under minimal supervision, the Lead Data Standards Analyst oversees the coordination and management of clinical data standards and production of standard datasets within SCHARP. The incumbent provides subject matter expertise in CDISC data standards, leads coordination efforts with SCHARP staff and network partners to standardize the collection and tabulation of clinical trials data, chairs the Data Standards Committee to govern CRF alignment with CDASH and change control for SCHARP SDTM and ADaM specifications, trains others in CDISC standards and SCHARP dataset configurations, reviews and approves draft SDTM and ADaM metadata and conversion specifications prior to implementation, configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse, and may supervise Data Standards Analysts in support of above described activities.

Core to the role is a deep understanding of data standards and data transformations, the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect.

The Lead Data Standards Analyst ensures that SCHARP studies produce high-quality CDISC datasets aligned with SCHARP standards and compliant with the latest published electronic regulatory submissions standards including:
• CDISC Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML.
• Controlled Terminology (CT) published by CDISC and NCI, as well as SCHARP-defined terminology.
• Electronic Common Technical Document (eCTD), Study Data Standards Documents, and other electronic submissions guidance issued by drug and medical device governing authorities.
• As Chair of the Data Standards Committee, governs the process for maintaining organizational data standards for clinical data collection, management, and reporting.
• Reviews and approves the draft of SDTM and ADaM metadata and conversion specifications prior to the implementation of these specifications in the clinical data warehouse.
• Configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse.
• Provides oversight to the SCHARP SDTM and ADaM data specifications - the operating clinical data models used for reporting and deriving clinical datasets and analysis datasets, respectively.
• Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP SDTM and advises to others in SCHARP on CDASH and ADaM.
• Works with study teams to lead the definition and documentation of per study SDTM metadata and conversion specifications and ensures alignment with organizational data standards.
• Provides study teams with insight to the SCHARP ADaM data specifications.
• Defines and documents per study clinical data transformations to SDTM+- from data collection formats such as CDASH.
• Implements clinical data transformations of source data to SCHARP SDTM using database ETL tools. Specifies complex transformations and consults with Programmers, as needed, to implement.
• Reviews and validates derived SCHARP SDTM and ADaM datasets using Pinnacle 21 to ensure compliance with published specifications and industry and regulatory requirements.
• Works with IT to identify and recommend enhancements to the database ETL toolset.
• Coordinates and may provide internal CDISC training to SCHARP and our partners as appropriate.
• Provides supervision and leadership by training and mentoring others involved with CDISC standards, SCHARP dataset configurations, and regulatory and/or sponsor-specific data requirements.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in Library Sciences, Informatics, Information Systems, Computer Science or other relative discipline.
• Seven (7) years of industry experience developing and implementing CDISC data standards.
• Working knowledge of CDASH, SDTM and ADaM.
• Excellent written and verbal communication skills, with the ability to work well in multi-faceted teams.
• Experience working with data documentation formats such as CSV, JSON, and XML.
• Expertise using Microsoft Excel.

PREFERRED QUALIFICATIONS:

• Experience building transformation pipelines using modern ETL tools such as IBM InfoSphere DataStage, Pentaho/Kettle, SQL Server Integration Services, or other.
• Experience supervising or mentoring others.
• Experience programming with a modern procedural, declarative, or statistical programming language such as SAS, Perl, Python, Shell or SQL.
• Experience working in an environment governed by Good Clinical Practices, Good Clinical Data Management Practices, or other FDA guidelines.
• Experience with Electronic Data Capture (EDC) systems.

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.

The annual base salary range for this position is from $107,536 to $169,957, and pay offered will be based on experience and qualifications.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).