Associate Director Biostatistics

Warman O'Brien; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Warman O'Brien is seeking an Associate Director of Biostatistics to provide strategic statistical leadership for oncology development programmes from Phase I to III. You will act as the lead statistician for assigned studies and collaborate with cross-functional teams to shape study design and evidence plans.

The ideal candidate will have a PhD or MSc in Statistics or Biostatistics, 10+ years of clinical drug development experience, and strong oncology expertise with track records in regulatory

Qualifications

• PhD or MSc in Statistics, Biostatistics or related field.
• 10+ years of clinical drug development experience.
• Strong oncology experience across Phase I–III.
• Experience supporting regulatory submissions.

Responsibilities

• Lead statistical strategy across oncology development programmes.
• Contribute to study design, development plans and evidence-generation strategies.
• Lead the development and review of protocols, SAPs and clinical study reports.
• Support regulatory submissions and health authority interactions.
• Provide statistical input into key programme and portfolio decisions.
• Apply innovative statistical methodologies, including Bayesian and adaptive approaches.

Skills

Statistical leadership

Oncology expertise

Clinical development

Regulatory submissions

Bayesian methods

Adaptive designs

Education

PhD in Statistics/Biostatistics

MSc in Statistics/Biostatistics

Job description

I’m supporting a growing, oncology-focused biopharma with the appointment of an Associate Director of Biostatistics.

This is a strategic, hands-on role providing statistical leadership across Phase I–III oncology development programmes. You will act as the lead statistician for assigned studies and programmes, working closely with cross functional teams.

Key responsibilities will include:

• Leading statistical strategy across oncology clinical development programmes
• Contributing to study design, development plans and evidence-generation strategies
• Leading the development and review of protocols, SAPs and clinical study reports
• Supporting regulatory submissions and health authority interactions
• Providing statistical input into key programme and portfolio decisions
• Applying innovative statistical methodologies, including Bayesian and adaptive approaches

The ideal candidate will bring:

• A PhD or MSc in Statistics, Biostatistics or a related discipline
• 10+ years’ experience within clinical drug development
• Strong oncology experience across Phase I–III studies
• Experience supporting or leading regulatory submissions