• Director of Biostatistics

    Astrix Technology (Cambridge, MA)


    Director of Biostatistics

     

    Clinical

     

    Cambridge, MA, US

    Pay Rate Low: 220000 | Pay Rate High: 240000

    + Added - 30/05/2025

     

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    Job Posting:

    _Our client is a clinical-stage biotechnology company pioneering therapies to address severe genetic diseases. They are currently seeking a Director of Biostatistics—a collaborative, open-minded leader with strong interpersonal skills and a passion for teamwork—to join their dynamic and mission-driven team._

     

    **Location:** Hybrid – Boston, MA

    **Compensation:** $230k/yr

    Summary:

    The Director of Biostatistics will lead statistical strategy across all clinical development phases. This role is key in guiding trial design, data analysis, and regulatory submissions, while managing CROs and collaborating across internal teams.

    Key Responsibilities:

    + Develop and execute statistical plans supporting clinical trials and regulatory filings

    + Design and review protocols, SAPs, and clinical study reports

    + Analyze trial data and present findings to technical and non-technical audiences

    + Represent Biostatistics in regulatory interactions (FDA, EMA)

    + Oversee CROs to ensure high-quality deliverables

    + Collaborate with Clinical Development, Data Management, and Medical Writing

    + Monitor industry trends and regulatory changes

    + Support SOP development and departmental budgeting

    Qualifications:

    + Ph.D. or Master’s in (Bio)Statistics with 10+ years in pharma/biotech

    + Deep knowledge of global regulatory guidelines and CDISC standards

    + Experience across Phases 1–3 and NDA submissions

    + Strong vendor/CRO management skills

    + Skilled in SAS and R; excellent communication and leadership abilities

    + Familiar with GCP, SOPs, and clinical compliance standards

     

    This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.