Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. 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 value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism 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 Data Standards Analyst II.

Under general supervision, the Data Standards Analyst II contributes to 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, supports coordination efforts with SCHARP staff and network partners to standardize the collection and tabulation of clinical trials data, drafts CRF Global Library form content as well as SDTM and ADaM metadata and conversion specifications, maintains awareness of publication updates from CDISC and other data standards or regulatory agencies that impact SCHARP data standards, and 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.

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.

Responsibilities

May include some or all of the following:

• Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP Standard SDTM and advises to others in SCHARP on CDASH, SDTM and ADaM standards and processes.
• 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.
• Draft and/or update Study Build Specifications and network Global Library content as needed based on requirements from SCHARP staff and network partners.
• Draft and/or review SDTM metadata and conversion specifications used for SDTM +/- transformations.
• 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 datasets using database ETL tools. Specifies complex transformations and consults with Programmers, as needed, to implement.
• Reviews and validates derived SCHARP SDTM datasets using Pinnacle 21 to ensure compliance with published specifications.
• Helps provide internal CDISC training to SCHARP and our partners as appropriate and provides routine updates to SCHARP staff to ensure current and new staff are aware of materials and training.
• Participates in process definitions and SOP development as needed.

Qualifications

Minimum Qualifications

• Bachelor's degree in Library Sciences, Informatics, Information Systems, Computer Science or other relative discipline, and at least two (2) years of experience in data management and/or SDTM implementation and conversion experience,
  • or,
• at least four (4) years of experience in data management and/or SDTM implementation and conversion experience.
• Working knowledge of CDASH, SDTM, and ADaM.Excellent written and verbal communication skills, with the ability to work well in multi-faceted teams.Experience as a member of a team completing regulatory submissions.
• 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.
• Knowledge of relational database structures and complex data systems.
• Experience programming with a modern procedural, declarative, or statistical programming language such as SAS, Perl, Python, Shell, JEXL, 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, Case Report Forms, and reading study Protocols.

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 $76,607 to $114,878 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).

Our Commitment to Diversity