Associate Director, Biostatistics - Remote Lead

Sumitomo Pharma; Lincoln (NE); 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. You will guide study design, data analysis, and regulatory submissions while partnering with cross‑functional teams to ensure scientific rigor and feasibility.

The role requires strong leadership, communication, and mentoring of statisticians, with expertise in Bayesian methods and complex trial designs.

Qualifications

• PhD/MS in Statistics or Biostatistics with pharma/biotech experience.
• 5+ years (PhD) or 8+ years (MS) in the pharmaceutical/biotechnology industry.
• Experience leading clinical development programs and trials.

Responsibilities

• Serve as biostatistics lead for one or more clinical development programs.
• Represent Biostatistics on cross-functional teams and influence key decisions.
• Lead regulatory interactions and prepare briefing documents and responses.
• Author or oversee statistical sections of protocols, SAS/SAS-based analyses, and submissions.
• Provide statistical interpretation and communicate risk-benefit to stakeholders.
• Identify risks and mitigation strategies in development plans.
• Oversee CRO/vendor statistical activities and timelines.
• Mentor statisticians and statistical programmers.
• Explore Bayesian methods and adaptive trial designs when appropriate.
• Contribute to governance and capability development.

Skills

Biostatistics leadership

Regulatory guidance knowledge

Clinical development strategy

Communication skills

Team mentorship

Strategic decision making

Cross-functional influence

Regulatory submissions support

Education

PhD in Statistics

MS in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs. You will guide study design, data analysis, and regulatory submissions while partnering with cross‑functional teams to ensure scientific rigor and feasibility.

The role requires strong leadership, communication, and mentoring of statisticians, with expertise in Bayesian methods and complex trial designs.