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Principal Biostatistician

CRISPR Therapeutics

Principal Biostatistician

Cambridge, MA
Full Time
Paid
  • Responsibilities

    Job Description

    COMPANY OVERVIEW

    At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.

    We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases.

    Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

    JOB SUMMARY

    The Principal Statistician is responsible for developing statistical solutions to optimally support all phases of clinical trials and decision making. The successful candidate will function as the study statistician and be accountable for study level deliverables. The role will assume key trial statistician responsibilities including statistical design, authoring of SAPs, overseeing production of analysis datasets and statistical outputs, and conducting just-in-time analyses and data exploration. Industry experience is preferred.

    RESPONSIBILITIES

    • Serve as study statistician across development programs
    • Perform management of in-house and/or outsourced biostatisticians/programmers, and mentor these team members as required
    • Perform trial statistician responsibilities as needed, including attendance of study team meetings, authoring SAPs, reviewing CRFs, design of phase 1-3 and PK studies, review of protocols/amendments, overseeing production of analysis datasets and statistical outputs, supporting regulatory filing as necessary, conducting exploratory data analyses, and performing just-in-time analyses
    • Apply innovative statistical approaches to study design, analysis and data exploration methodologies
    • Plan and track study level activities within programs, including resources; ensure CRO timelines and objectives are met
    • Help establish and maintain company data standards, within and across programs
    • Serve as a general clinical development and statistical resource at the company

    QUALIFICATIONS

    • PhD in Biostatistics or related discipline with 3+ years biopharmaceutical industry experience; MS in Biostatistics or related discipline with 6+ years biopharmaceutical industry experience will be considered
    • Experience with Bayesian methods preferred
    • Proven knowledge and expertise in statistics and its applications to clinical trials
    • Fluent with statistical software including SAS, R, EAST, WinBUGS among others
    • Motivated with ability to work independently
    • Excellent communication and presentation skills
    • Team player with ability to work successfully across functions
    • Innovative, flexible mindset

    CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

    To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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