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    Biostatistician - Los Angeles, United States - GForce Life Sciences

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    GForce Life Sciences background
    Description
    Summary

    Our client, a leading med tech company with over 125 years of experience, has engaged GForce Life Sciences to provide a Sr.

    Biostatistician .

    This position will report to the Sr. Director of Biostatistics

    within the Biostatistics department. This individual will be responsible for collaborating with external partners handling delicate conversations to push a neurology initiative forward. This position requires the ability to work on solutions for analysis plans and have experience with pharmaceutical study designs.

    Duties / Expectations of Role
    Responsible for consulting on the design of clinical trials and statistical analysis methodology for studies
    Recommend appropriate statistical methodology for the evaluation of analytical and clinical study data
    Interprets and evaluates test data and results of complex studies and develops appropriate recommendations
    Perform detailed review of clinical study protocols and development plans to ensure that the appropriate sample size and statistical methods are specified to support study endpoints
    Author statistical sections of protocols for development-phase projects
    Ensure that clinical monitoring plans, data management plans, and statistical analysis plans are harmonized and ensure delivery of high-quality data and analysis results for regulatory submissions
    Lead discussions and interacts with members of the Data Management and Clinical Affairs teams to align statistical endpoints of the clinical study to data collection, monitoring, and analysis activities
    Author Statistical Analysis Plans (SAP) for clinical studies, maintains plan through life cycle of study, and executes analyses per plan
    Develop statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports
    Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations
    Ensure data specifications align with statistical analysis requirements and goals
    Provide complex specifications and directions to clinical data analysts for creation of ADS and/or TLFs

    Mandatory Requirements
    Minimum educational background of MS in statistics/biostatistics or other quantitative field. Exceptional candidates with backgrounds bridging biological science and biostatistics will be considered
    At least 5 years of experience in biostatistics supporting development of medical diagnostics/devices and pharmaceutical
    Must demonstrate progressive experience in consulting and serving as lead consulting biostatistician on product development projects
    Proficiency in statistical programming (R) and query of relational database systems (SQL)
    Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical). Experience with Open Clinica preferred

    Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations.

    Knowledge of diagnostic clinical trial statistics is required.
    Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems
    Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is a plus
    Experience with analysis of complex data from multiple source
    Ability to work independently and in project teams. Highly motivated and driven to exceed expectations
    Strong communication skills in English, written and spoken. Strong ability for public speaking in audiences with mixed backgrounds. Able to distill complex statistical concepts in simpler terms to generalized audiences
    Direct Neurology experience (i.e. ALS, Alzheimers and/or MS)

    Term & Start

    Start Date:

    ASAP
    12 Month+ Contract
    Remote

    Benefits
    401(k) matching
    Employer contributed competitive health benefits (medical, dental, vision)
    Philanthropy driven culture
    Consultant engagement social activities

    #J-18808-Ljbffr

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