Senior Biostatistics Lead, Clinical Development (Remote)

Sumitomo Pharma; Madison (WI); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. seeks an Associate Director of Biostatistics to provide statistical leadership across clinical development programs.

The role focuses on study design, data analysis, regulatory submissions, and external collaborations, blending scientific rigor with operational feasibility. The position requires leadership in Bayesian methods, complex trial designs, and governance, with mentorship to statisticians and programmers.

Qualifications

• PhD in Statistics/Biostatistics or related field with extensive pharma/biotech experience.
• Experience leading clinical development programs and trials.
• Strong regulatory interactions experience preferred.
• Oncology or hematology development experience preferred.
• Experience overseeing CROs or external statistical partners.

Responsibilities

• Lead statistical strategy for one or more clinical programs.
• Partner with cross-functional teams to align with regulatory goals.
• Manage interactions with regulatory authorities and prepare briefing documents.
• Oversee statistical sections of protocols, SAPs, and submissions.
• Provide mentorship and develop capabilities within the statistics group.

Skills

Biostatistics leadership

Study design

Regulatory affairs

Briefing documents

CRO oversight

Bayesian methods

Governance & standards

Mentorship

Data interpretation

Education

PhD in Statistics

MS with 8+ years pharma/biotech

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. seeks an Associate Director of Biostatistics to provide statistical leadership across clinical development programs.

The role focuses on study design, data analysis, regulatory submissions, and external collaborations, blending scientific rigor with operational feasibility. The position requires leadership in Bayesian methods, complex trial designs, and governance, with mentorship to statisticians and programmers.