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    Manager Statistical Programming - South Plainfield, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences South Plainfield, United States

    3 weeks ago

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    Description
    Title: Manager Statistical Programming - Oncology, NJ, NY (Remote).

    Summary:
    • The Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s).
    • The incumbent will work with management and study team, plan and manage the implementation and execution of programming project standard to support from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests.
    In this role, a typical day might include the following:
    • Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Coordinate programming documentations and specifications for multiple studies following programming standards and processes.
    • Demonstrate company values and act as a role model by demonstrating excellence, competence, collaboration, innovation, respect, ownership, and accountability.
    • Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management.
    • Act as a technical resource for programming group to provide advice on complex programming tasks, standards, and processes.
    • Support global regulatory authority submissions including preparing programming deliverable for submission and working closely with partnering functions to address health authority requests.
    • Participate and contribute towards department goals and SME topics.
    This role may be for you if have:
    • Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. is a plus.
    • Understanding of pharmaceutical clinical development across multiple therapeutic areas (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and good knowledge of regulatory submissions and requirements
    • Ability to work on global interdisciplinary teams. Good organizational, interpersonal, communication, and leadership skills. Establish and maintain effective working relationships with coworkers, managers, and clients.
    • Ability to effectively manage multiple tasks and projects.
    • Problem solving and innovative skills that demonstrate initiative and motivation.
    • Ability to influence others, mentor, and coach junior programmers to achieve results.
    • TO BE CONSIDERED FOR THIS OPPORTUNITY WE ARE LOOKING FOR:
    • Bachelor's in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 8+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.
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