Senior Biostatistics Lead, Remote Clinical Development

Sumitomo Pharma; Topeka (KS); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across clinical development programs, including planning, design, analysis, and regulatory submissions. The role partners with cross-functional teams to ensure rigorous statistics and regulator-ready deliverables, with a strong emphasis on Bayesian methods and innovative trial designs.

Primarily remote with occasional on-site meetings; base salary range $165,800 to $207,200 per

Qualifications

• PhD in Statistics, Biostatistics, or related field with ≥5 years in pharma.
• Significant experience leading clinical development programs.
• Experience with regulatory interactions desired.
• Oncology/hematology experience preferred.
• Overseeing CROs and external partners required.

Responsibilities

• Lead statistical input for development plans and study designs.
• Represent Biostatistics on cross-functional teams.
• Lead interactions with regulatory authorities.
• Draft statistical sections of protocols and SAPs.
• Provide interpretation of results and risk mitigation.
• Manage CRO/vendor statistics activities.
• Mentor statisticians and programmers.
• Apply Bayesian and adaptive trial designs when appropriate.

Skills

Statistical leadership

Regulatory knowledge

Bayesian methods

Cross-functional leadership

Data analysis

Education

PhD in Statistics

MS in Biostatistics

Tools

SAS

R

CDISC

Job description

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across clinical development programs, including planning, design, analysis, and regulatory submissions. The role partners with cross-functional teams to ensure rigorous statistics and regulator-ready deliverables, with a strong emphasis on Bayesian methods and innovative trial designs.

Primarily remote with occasional on-site meetings; base salary range $165,800 to $207,200 per