• Senior Manager Clinical Programming

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10565
  • Responsibilities

    The Sr. Manager Clinical Programming manages compound programming activities including the planning, coordination, and execution of the statistical programming functions in support of the clinical research project.

    • Assist in departmental and clinical budgetary activities.
    • Represent groups in providing solutions to technical problems. Coordinate validation of analyses generated by Analysis Programming Group. Provide mentoring, on-the-job training, and supervision of new contractors.
    • Provides analysis programming including generating reports, tables, listings, graphs, statistical analyses, and applications to satisfactorily fulfill requirements. While some programming is maintenance programming (modifying existing programs), the majority is writing new programs.
    • Manage Clinical Programming group activities. Develop group’s training manuals to promote standard processes and procedures. Ensure departmental policies, procedures, and standards are adhered to. Evaluate group’s project progress and recommends changes in procedures and objectives. Collaborate with other function managers and departments (i.e., Safety, Medical Writing, Clinical, Biostatistics, and Quality Management) to ensure that their requirements are satisfactorily fulfilled.

    Qualifications

    Required knowledge and skills:

    • Knowledge of SAS programming, as well as relational database structures and data management processes
    • Knowledge of regulatory requirements as they relate to programming and validation
    • Knowledge of company’s products, tools, and processes as well as clinical trial process development
    • Strong computer skills
    • Excellent communication and interpersonal skills

    Required Education and Related Experience:

    • Master’s degree in Computer Science with 8 years of SAS experience + 5 years of experience in pharmaceutical industry
    • Experience in developing statistical base programming and database management

    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 maental 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.

    Disclaimer

    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.

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