Celldex Therapeutics

  • Senior/Manager Statistical Programmer

    Job Locations US-NJ-Hampton
  • Overview

    Celldex Therapeutics seeks an experienced Statistical Programmer to join our company as a Senior / Manager Programmer and support Celldex drug development. This position will be based in Hampton, NJ.

    Responsibilities

    • Multiple in-house programming activities such as CSR programming, regulatory filings, ad-hoc analysis, publication requests, IB, DSUR, database pooling and reporting from multiple studies.
    • Work with CROs to ensure quality, including standard programming practice, validation, and documentation.
    • Review clinical study documents including CRF design, SDTM specs, and edit checks.
    • Contribute to developing and maintaining a standardized programming process including SAS macros, programming specs (ADaM), and validation process.
    • Utilize the SAS technical expertise or other programming skills to help build the programming infrastructure and tools.
    • Contribute to the development of standard TLGs, ADaM templates, and other statistical documents.

    Qualifications

    Required Skills:

    • Knowledge of SDTM, ADaM, and CDISC requirements for regulatory submissions.
    • Ability of handle multiple priorities with multiple timelines.
    • Excellent team player. Excellent written and verbal communication skills.
    • Experience with data pooling to support Integrated Summary of Safety (ISS) / Efficacy (ISE) preferred.
    • Experience as a project lead coordinating programming activities preferred.

    Education/Experience:

    • Completed MS degree in Computer Science, Math, Statistics (or related field) and at least 3 years’ industrial experience required; or completed BS degree and at least 5 years’ experience required.
    • Oncology experience preferred.

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