Immunomedics, Inc.

  • Principal Biostatistician - Oncology

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(10/17/2019 2:10 PM)
    Job ID
    2019-1550
    # of Openings
    1
    Category
    Clinical
  • Overview

    The Principal Biostatistician works directly with the medical project team to provide input into and insure the appropriateness of the statistical analysis methods described in the clinical study protocol. S/he develops statistical analysis plans consistent with the clinical trial primary safety and efficacy end points. The Biostatistician reports to the Director of Biostatistics.

    Responsibilities

    • Provides advanced input into the statistical sections and overall consistency of the clinical study report.
    • Develops and reviews statistical analysis plans.
    • Determines appropriate analysis for clinical endpoints based on the protocol and clinical team.
    • Responsible for the datasets and outputs for the clinical trial and insures their correctness, quality and consistency with the statistical analysis plan
    • Develops analysis (ADaM) dataset specifications to assist the statistical programming group in developing the datasets required for planned tables listing and figures.
    • Provide guidance for tables, listings and figures programming specifications as needed
    • Works with the data management team to review CRFs to insure that data collected meets the protocol requirements and helps insure data quality throughout the trial
    • Performs the preparation, execution, reporting and documentation of high-quality statistical analysis according to the statistical analysis plan
    • Responsible for statistical considerations in FDA submissions
    • Provides support to Data Safety Monitoring Boards by preparing and presenting the appropriate output
    • Generates sample size calculations appropriate for the primary endpoint based on the protocol
    • Prepares and reviews statistical methods and results sections for the clinical study report with the medical writers and clinical team
    • Generates and reviews randomization schedules per protocol and randomization schema
    • Assists in the development of project timelines, Standard Operating Procedures and guidance documents
    • Administrates as appropriate the receipt, collation and incorporation of review comments needed for completion of the statistical analysis plan, and result
    • Communicates competently and independently with the clinical team to coordinate statistical and programming activities of the project.

    Qualifications

    • The ideal candidate will possess an advanced scientific degree MS in statistics or equivalent or PhD in statistics or equivalent.
    • 5 or more years of statistical analysis experience in the pharmaceutical or biotechnology industry or at a CRO preferably in oncology
    • Strong knowledge and experience in SAS (SAS STAT, SAS BASE, SAS MACROS, SAS/ODS and SAS GRAPH)
    • Strong knowledge of study design and statistical analysis methods (e.g. survival analysis techniques, summary descriptive statistics)
    • Working knowledge of SDTM/ADaM
    • Knowledge with ICH, GCP, and regulatory guidelines
    • Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time
    • Ability to work professionally and proactively with diverse team members
    • Excellent verbal and written communication and the ability to write and edit complex material to ensure accuracy clarity and effectiveness
    • Understanding of the drug development process
    • Self-motivated, hardworking, dependable and positive team-oriented personality
    • Ability to communicate effectively with statistical programmers
    • Current knowledge of US and EU regulatory requirements and guidelines for documents; knowledge of eCTD requirements with respect to structure, format and content
    • Strong PC Experience and demonstrated proficiency with the MS Office Suite applications, Adobe Acrobat, and electronic document management systems

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