Radius Health, Inc.

  • Associate/Director, Biostatistics

    Job Locations US-MA-Waltham | US-NJ-Parsippany | US-New York
    Posted Date 3 months ago(8/7/2018 8:20 AM)
    Job ID
    2018-1683
    # of Openings
    1
    Category
    Biometrics - Dept
  • Overview

    The Associate Director or Director, Biostatistics will be responsible for all statistical activities of assigned clinical studies. The incumbent will be the statistical lead and point-of-contact on statistical activities for the clinical study teams.

    Potentially able to work remote!

    Responsibilities

    • Plan, manage, and perform statistical tasks to support clinical trials, publications and regulatory submissions
    • Apply and ensure statistical approaches complying with regulatory guidelines to study design, analysis and data exploration methodologies, including adaptive methods to dose finding
    • Represent Biostatistics on the assigned study teams and serve as the statistical contact for the clinical studies
    • Participate in vendor selection and oversee statistical activities performed by vendors
    • Provide statistical support to the planning, authoring, and review of manuscripts, publications and other scientific data disclosures
    • Contribute to regulatory document preparations, including meeting briefing package, integrated analysis reports, and CTD summaries
    • Collaborate with internal and/or external team members to plan and execute biostatistical deliverables supporting the clinical studies
    • Contribute to the establishment, maintenance and improvement of department/company processes and procedures
    • Assist in the standardization and development of best practices to improve quality, efficiency and effectiveness of the department/company

    Qualifications

    • PhD or DrPH in Biostatistics, Statistics, Epidemiology, or Mathematics with at least 4 years of pharmaceutical experience OR MS in Biostatistics, Statistics, Epidemiology, or Mathematics with at least 7 years of pharmaceutical experience
    • Oncology experience preferred
    • Strong technical abilities and skills in statistical methodologies, with working knowledge of using SAS, R, EAST and other statistical software
    • Extensive knowledge of drug development and regulatory guidance/requirements
    • Effective communication, interpersonal, problem solving and analytical skills
    • Experience in regulatory submissions (eg, NDA/MAA) and regulatory review/approval process

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