Associate Director, Biostatistics — Clinical Development Lead

Sumitomo Pharma America, Inc; Town of Marlborough (NY); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an Associate Director of Biostatistics to provide strategic statistical leadership across one or more clinical development programs.

The role involves designing studies, guiding analysis plans, and collaborating with cross-functional teams to ensure rigorous, regulatory-aligned outputs. You will lead statistical interactions with regulators, prepare briefing documents, and mentor statisticians and programmers.

Qualifications

• PhD in Statistics, Biostatistics, or related field with at least 5 years of relevant pharma/biotech experience.
• Significant experience providing statistical leadership for clinical development programs and trials.
• Experience supporting regulatory interactions and submissions is strongly preferred.

Responsibilities

• Lead statistical input for clinical development plans and study designs.
• Represent Biostatistics on cross-functional teams and ensure statistical considerations in key decisions.
• Lead regulatory interactions, briefing documents, and responses to questions.

Skills

Bayesian methods

Statistical leadership

Regulatory collaboration

Complex trial designs

Communication to leadership

Education

PhD in Statistics/Biostatistics

MS with 8+ years pharma/biotech

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking an Associate Director of Biostatistics to provide strategic statistical leadership across one or more clinical development programs.

The role involves designing studies, guiding analysis plans, and collaborating with cross-functional teams to ensure rigorous, regulatory-aligned outputs. You will lead statistical interactions with regulators, prepare briefing documents, and mentor statisticians and programmers.