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Astrix

Director of Biostatistics

Astrix, Cambridge, Massachusetts, us, 02140

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Director of Biostatistics

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Astrix

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!

Seniority level Director

Employment type Full-time

Job function Research, Analyst, and Information Technology

Industries IT Services and IT Consulting

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