• SDTM Specialist

    Job ID
    13001
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Biostatistics, Bioinformatics and Computational Biology
  • Overview

    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 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.


    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. Under general supervision, the Data Standards Analyst 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, coordinates and/or leads CDISC working groups, drafts SDTM and ADaM metadata and conversion specifications as well as CRF Global Library form content, 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

    • Reviews study builds to ensure they are following Global Library specifications and review and/or approve of the changes as necessary.
    • Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP SDTM and advises to others in SCHARP on CDASH, SDTM 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.
    • Draft and/or update Global Library form content as needed based on requirements from SCHARP staff and network partners.
    • Draft and/or review SDTM metadata and conversion specifications and final datasets.
    • 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 datasets using Pinnacle 21 to ensure compliance with published specifications.
    • Coordinates 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

    Required

    • Bachelor’s degree in Library Sciences, Informatics, Information Systems, Computer Science or other relative discipline.
    • At least two years of experience in data management in clinical research 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.
    • Expertise using Microsoft Excel.

    Preferred

    • 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 working with data documentation formats such as CSV, JSON, and XML.
    • 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.

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

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