Remote Associate Director, Biostatistics - Clinical

Sumitomo Pharma America; United States; Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs, guide study design, analyses, and regulatory submissions, and collaborate with cross-functional teams to ensure rigorous, timely decision-making.

The role emphasizes mentoring statisticians, managing CROs, and applying Bayesian methods or adaptive designs when appropriate, with remote-first work and periodic on-site meetings; travel domestically and

Qualifications

• PhD in Statistics or Biostatistics with 5+ years in pharma/biotech.
• MS with 8+ years in pharma/biotech acceptable.
• Experience leading clinical development programs preferred.

Responsibilities

• Lead statistical input for clinical development plans and study designs.
• Oversee statistical sections of protocols and submissions.
• Mentor statisticians and manage CRO/vendor activities.
• Communicate statistical results clearly to non-technical stakeholders.

Skills

Clinical trial design

Regulatory interactions

Cross-functional collaboration

Bayesian methods

Statistical leadership

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

SAS

R

CDISC

Job description

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs, guide study design, analyses, and regulatory submissions, and collaborate with cross-functional teams to ensure rigorous, timely decision-making.

The role emphasizes mentoring statisticians, managing CROs, and applying Bayesian methods or adaptive designs when appropriate, with remote-first work and periodic on-site meetings; travel domestically and