Director Biostatistics

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

Job summary

Warman O’Brien is seeking an Associate Director of Biostatistics for an oncology-focused biopharma client in Massachusetts. This strategic, hands-on role leads statistical leadership across Phase I-III oncology programmes and serves as lead statistician for assigned studies, partnering with cross-functional teams.

The ideal candidate brings a PhD or MSc in Statistics/Biostatistics with 10+ years in clinical drug development and strong oncology experience, including regulatory submissions.

Qualifications

• PhD or MSc in Statistics/Biostatistics or related discipline
• 10+ years in clinical drug development
• Strong oncology experience across Phase I-III studies
• Experience supporting or leading regulatory submissions

Responsibilities

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

Skills

Biostatistics leadership

Bayesian methods

Adaptive design

Clinical development

Education

PhD or MSc in Statistics/Biostatistics

Tools

SAS

R

Regulatory submissions experience

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