Director of Biostatistics

Astrix; Cambridge (MA); Hybrid; USD 230,000; Full time

Job summary

A leading biotechnology company is looking for a Director of Biostatistics to spearhead statistical strategy throughout all phases of clinical development. This role will involve critical responsibilities in trial design and analysis while collaborating cross-functionally within a dynamic team. Candidates should have a robust statistical background, including at least a Ph.D. and extensive industry experience.

Qualifications

• 10+ years in pharma/biotech.
• Knowledge of global regulatory guidelines.
• Experience across Phases 1-3 and NDA submissions.

Responsibilities

• Develop and execute statistical plans for clinical trials.
• Design and review protocols and clinical study reports.
• Collaborate with internal teams and oversee CROs.

Skills

SAS

R

Leadership

Communication

Vendor Management

Education

Ph.D. or Master’s in (Bio)Statistics

Job description

Join to apply for the Director of Biostatistics role at 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:

1. Develop and execute statistical plans supporting clinical trials and regulatory filings
2. Design and review protocols, SAPs, and clinical study reports
3. Analyze trial data and present findings to technical and non-technical audiences
4. Represent Biostatistics in regulatory interactions (FDA, EMA)
5. Oversee CROs to ensure high-quality deliverables
6. Collaborate with Clinical Development, Data Management, and Medical Writing
7. Monitor industry trends and regulatory changes
8. Support SOP development and departmental budgeting

Qualifications:

1. Ph.D. or Master’s in (Bio)Statistics with 10+ years in pharma/biotech
2. Deep knowledge of global regulatory guidelines and CDISC standards
3. Experience across Phases 1–3 and NDA submissions
4. Strong vendor/CRO management skills
5. Skilled in SAS and R; excellent communication and leadership abilities
6. 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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