Director Biostatistics

Barrington James; San Francisco (CA); Hybrid; USD 180,000 - 265,000; Full time

Benefits offered by this job

Medical insurance

401(k)

Paid maternity leave

Vision insurance

Pension plan

Child care support

Paid paternity leave

Student loan assistance

Disability insurance

Tuition assistance

Job summary

A clinical-stage biotech company is hiring a Director or Sr. Director of Biostatistics to lead biostatistical strategy across various programs. The ideal candidate will have over 10 years of experience in clinical biostatistics and will collaborate with cross-functional teams to drive study design and regulatory submissions. This position is hybrid, requiring onsite presence 3+ days a week.

Qualifications

• PhD in Biostatistics or MS with strong experience.
• 10+ years in clinical biostatistics within biotech, pharma, or CRO.
• Expertise in FDA/EMA guidelines.

Responsibilities

• Lead biostatistics and programming for global clinical trials.
• Define and uphold statistical standards.
• Contribute to regulatory strategy and submission planning.

Skills

Clinical trial design

Cross-functional collaboration

Regulatory submissions

Biostatistical strategy

Leadership

Education

PhD in Biostatistics

Tools

SAS

Job description

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This range is provided by Barrington James. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$180,000.00/yr - $265,000.00/yr

Direct message the job poster from Barrington James

Team Manager (Clinical Development, Medical Affairs and Biometrics) at Barrington James

Location: Hybrid – Onsite 3+ days/week | Clinical-Stage Biotech

A clinical-stage biotech company is hiring a Director or Sr. Director of Biostatistics to lead biostatistical strategy across oncology, immunology, and inflammation programs. This role will drive study design, regulatory submissions, and vendor oversight while collaborating closely with cross-functional teams.

Responsibilities:

• Lead biostatistics and programming for global clinical trials
• Define and uphold statistical standards; review SAPs, protocols, CSRs, CDISC/ADaM datasets
• Oversee CROs and vendors to ensure quality and timely deliverables
• Contribute to regulatory strategy and submission planning
• Build and mentor a high-performing biometrics team

Qualifications:

• PhD in Biostatistics (MS considered with strong experience)
• 10+ years in clinical biostatistics (biotech/pharma/CRO)
• Expertise in clinical trial design, FDA/EMA guidelines, and SAS
• Proven experience with regulatory submissions and CRO oversight
• Strong leadership and cross-functional collaboration skills

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

• Industries

  Research Services and Hospitals and Health Care

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Inferred from the description for this job

Medical insurance

401(k)

Paid maternity leave

Vision insurance

Pension plan

Child care support

Paid paternity leave

Student loan assistance

Disability insurance

Tuition assistance

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