Remote Associate Director, Biostatistics (Oncology)

Sumitomo Pharma America, Inc.; Marlborough (MA); 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 clinical development programs.

You will partner with cross-functional leaders to ensure rigorous statistical plans, data analysis, and regulatory submissions align with program objectives. The role requires PhD in Statistics/Biostatistics (or MS with extensive pharma experience) and expertise in SAS/R, Bayesian methods, and adaptive trial designs.

Qualifications

• Broad knowledge of statistical principles in drug development.
• Regulatory guidance from FDA/EMA/PMDA and ICH.
• Experience with Bayesian methods and adaptive trial designs is preferred.
• Proficiency in SAS and R for statistical computing.

Responsibilities

• Lead statistical strategy for one or more clinical programs.
• Interface with cross-functional teams to integrate statistics into development decisions.
• Oversee statistical sections of protocols, SAPs, regulatory submissions.
• Mentor statisticians and external vendors; manage risks and mitigation.

Skills

Statistical leadership

SAS

R

Regulatory guidance knowledge

Complex trial designs

Education

PhD in Statistics/Biostatistics

MS with 8+ years in pharma/biotech

Tools

CDISC

Job description

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

You will partner with cross-functional leaders to ensure rigorous statistical plans, data analysis, and regulatory submissions align with program objectives. The role requires PhD in Statistics/Biostatistics (or MS with extensive pharma experience) and expertise in SAS/R, Bayesian methods, and adaptive trial designs.