Immunomedics, Inc.

  • Principal Statistical Programmer - SAS

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(8/28/2019 2:29 PM)
    Job ID
    2019-1458
    # of Openings
    1
    Category
    Data Management
  • Overview

    The Principal Consultant of Statistical Programmer is an independent programmer and analyst responsible for delivery of the technical components required to support the analysis and reporting for various clinical development projects. He/She will provide broad expertise in all aspects of the statistical programming field. Critical project activities include reporting dataset development, statistical and clinical reporting, validation and submissions support.

    Responsibilities

    • Provide clinical data management and biostatistical programming support for various phases of clinical studies (reference International Council for Harmonisation (ICH) E6 R2) whichleads to generation of high-quality, reliable, and statistically sound data from clinical trials.
    • Assist in the production and Quality Control (QC) of analysis plans, analysis dataset specifications, programming specifications.
    • Independently, perform programming and analysis support of analysis datasets, listings, figures, and summary tables according to specifications
    • Ensure quality control (QC) performed on all process and technical activities related to derived datasets, table, listing, and figure programming in accordance with company quality standards, International Council for Harmonisation standards, Good Clinical Practice standards, and/or other international regulatory requirements
    • Provide programming support to the regulatory submissions including data submission package and define.xml development;
    • Communicate effectively within a multi-disciplinary project team to complete assigned tasks on time and with high quality;
    • Understand regulatory requirements concerning industry technical standards (e.g., Clinical Data Interchange Standards Consortium, 21 CFR (Code of Federal Regulations) Part 11, electronic submissions, etc.);
    • Reviews and makes recommendations for process development and improvement. Contribute to the development of best practice to improve quality, efficiency and effectiveness.
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    Qualifications

    Requirements:

    • Bachelor's degree in life science, statistics, mathematics, computer science, or related field required; Master's degree preferred.
    • 7+ years of Statistical Analysis Programming experience in biotech or pharmaceutical industry.
    • Solid knowledge and experience of Clinical Data Interchange Standards Consortium (CDISC) industry standards including Study Data Tabulation Model (STDM) and Analysis Data Model (ADaM)
    • Oncology and Immuno-Oncology therapeutic area and submission experience is preferred.
    • Detail oriented and strong organizational and communication skills.
    • Ability to work in a team environment.

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