• Manager, Data Standards and Programming

    Job Locations US-MD-Rockville
    Requisition ID
    2018-10523
  • Responsibilities

    Position Summary:

     

    • Implement, maintain and update global SDTM specification and controlled terminologies.
    • Work collectively with Data Management personnel to review global CDASH specifications and EDC/eSource global libraries.
    • Work collaboratively with Data Management Lead to define study-specific SDTM domains, variables and codelists.
    • Manage MDR (metadata repository) and associated DSP (data standardization platform) system to upgrade, develop workaround solutions, and provide training as needed.
    • Develop programming standards, templates and library to ensure consistency, improve quality and reduce SDTM programming timeline for clinical studies.
    • Develop custom validation check, in addition to Pinnacle 21, to ensure conformance and quality of the raw and SDTM data.
    • Assist in developing Working Procedures, Best Practices and training materials to support SDTM transformation.
    • Perform SDTM transformation to support clinical studies in accordance with SOPs, guidance documents, and utilizing a data conversion tool.
    • Perform SDTM annotations on blank Case Report forms for clinical studies to support regulatory submissions.
    • Generate define.xml for SDTM data as required for regulatory submission.
    • Review and update Study Data Reviewer’s Guide to document any standard conformance related issues.
    • Perform quality control of CDISC SDTM domain output in accordance with SOPs, guidance documents and utilizing validation tools, including Pinnacle 21.
    • Review and validate SDTM transfer from CRO and other Otsuka affiliates and partners.
    • Provide support to the loading of SDTM data into Otsuka Global Data Warehouse.
    • Archive SDTM related documents to ensure inspection-ready by regulatory agencies.
    • Support submission-related deliverables including SDTM datasets, annotated CRF, Study Data Reviewer’s Guide.
    • Coordinate with Clinical Programming, Biostatistician and Data Management personnel to resolve any data format related issues.
    • Provide training to internal and CRO personnel on MDR system and SDTM as necessary.
    • Other tasks assigned by supervisor of Data Management.

    Qualifications

    Required:

    • Bachelor’s degree with minimum of 8 yrs data management or programming experience in the pharmaceutical industry or an advanced degree with minimum 5 yrs relevant experience.
    • Knowledge and experiences of CDISC industry standards, including SDTM, CDASH and controlled terminologies.
    • Strong SAS programming skills
    • Strong understanding of medical concepts and terminology
    • Knowledge of data management and programming practices
    • Knowledge of regulatory submission requirements for data standards
    • Know how/when to apply organizational policy or procedures to a variety of situations
    • Strong oral and written communication/presentation skills
    • Up to 5% travel between Rockville and Princeton, based upon business needs.

    Preferred:

    • Prior experience managing on metadata repository.
    • Experience managing team of direct or indirect reports.

     

    Come discover more about Otsuka and our benefit offerings; click here for more information

     

    Disclaimer:

    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

     

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 


    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

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