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    Opportunity: Principal Biostatistician -- Early Development (#1404043) @ Bristol-Myers Squibb -- Princeton, NJ (US)
    Submitted by Jody Aikawa; posted on Thursday, September 25, 2014

    RESPONSIBILITIES

    The Principal Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. This role has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This role has significant stakeholder management responsibility with business partners on their team and may interact with external vendors, key opinion leaders and regulatory agencies.

    Responsibilities:
    • Provide statistical leadership for clinical development programs in phases I - IIa.
    • Statistical collaboration in clinical program & study design, biomarker & clinical pharmacology strategy, methodology, data analysis & interpretation.
    • Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
    • Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product
    • Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
    • Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information
    • Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
    • Communicates effectively with clinical and regulatory partners and external opinion leaders
    • Builds the external reputation of BMS R&D via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation
    • Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
    • Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
    • Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles
    • Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
    • Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
    • Keeps up-to-date with state-of-the art applied statistical methodology

    REQUIREMENTS

    • PhD in (bio)statistics, statistical genetics or scientific field w/strong statistical theory and methods.
    • Minimum of 3 – 5 years of experience in clinical trials within the pharmaceutical or biotech industry.
    • Strong collaboration and leadership skills.
    • Skilled in analysis of pharmacokinetic, pharmacodynamic, safety, efficacy & biomarker data, with an understanding of multiplicity issues; high-throughput genetic & genomic or strong background in adaptive design (Bayesian or CRM) preferred.
    • Experienced with standard and advanced statistical methods.
    • Expertise in SAS required, S-Plus or R preferred, including advanced statistical analysis, data manipulation, graphing & good software design.
    • Good understanding of regulatory requirements & clinical trial design.
    • Knowledge of and ability to learn biomarker biology and incorporate biology into analysis & interpretation.
    • Ability to work as part of a highly skilled team.
    • Ability to adapt to evolving biological knowledge with creativity & rigor.

    HOW TO APPLY

    To apply for this position, please use the following URL: ars2.equest.com/?res[...]d0521

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