• Director, Biometrics

    Job Locations US-IL-Chicago
    ID
    2019-1136
    Category
    Clinical Development
    Type
    Full-Time
  • Overview

    Xeris is searching for a Director, Biometrics to join our team in Chicago. This individual is a very senior biostatistician who provides technical expertise and statistical leadership. This individual will serve as the company leader in biostatistics for all clinical development programs and will provide oversight of data management activities. They will provide direction for clinical trial study design development, sample size and power calculations and provide input and consulting for future protocols. They will review and support regulatory filings in the US and Europe. They will assist with data management and statistical vendor reviews, selection, and oversight. This person will be responsible for setting up a standardized file structure and data repository for the company for final study database and statistical deliverables.

    Responsibilities

    • Develops and oversees biostatistics operations and clinical data management functions, in support of corporate activities.
    • Provides expert statistical strategy on critical projects, supports interactions with regulatory authorities and key opinion leaders, and is responsible for the statistical soundness of all statistical input and deliverables for the assigned projects.
    • Author and provide input on relevant sections of research and clinical protocols including endpoint specification, study logistics, sample size determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).
    • Oversee data management practices to ensure accuracy of clinical study data.
    • Manage data release and review meetings for studies; reviews and participates in finalizing and obtaining approval of final manuscript or final reports for studies.
    • Provide project support to statistical deliverables through the specification/review of tables, figures and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations.
    • Acts as a consultant to all project teams and advises on available statistical methodologies and their application in drug development
    • Undertake the preparation of final reports, including the production of tables, listings and figures, and report writing.
    • Produce ad hoc data summaries when requested during the course of a trial.
    • Extract information from various vendor and corporate databases during the course of a trial e.g. summaries, data listings, study data sets.
    • Monitors projects quality, timeliness, and budgets to ensure successful completion and project expectations are met.
    • Remains current with methodology development in statistics, regulatory guidelines, and industry trends in drug development.
    • May be accountable for three or more concurrent studies.

    Qualifications

    • PhD in biostatistics with a minimum of 10-15 years related experience.
    • Hands-on experience supporting clinical studies and working with clinical teams.
    • Knowledge of SAS software and general computing in the pharmaceutical area as it relates to clinical trials in research and development.
    • Understanding of FDA guidance’s and implementation.
    • Strong working knowledge of statistical data analysis and data management principles.
    • Knowledge of the drug discovery and development process and clinical trial methodology as applicable.
    • Global clinical development experience preferred.
    • General project management skills.
    • Good oral and written communication.
    • Good collaborative skills and ability to work with a cross-functional team.

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