Remote Biostatistics Lead — Clinical Development Strategy

Sumitomo Pharma; Pierre (SD); Remote; USD 166,000 - 207,000; Full time

Benefits offered by this job

Merit-based salary increases

401(k) plan

Medical, dental, vision, life and long

Disability insurances

Flexible paid time off

Job summary

Sumitomo Pharma America (SMPA) is seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs. You will partner with cross-functional teams to shape design, analyses, and regulatory submissions, while mentoring statisticians and collaborating with regulatory authorities as needed.

The role emphasizes Bayesian/complex designs and quantitative decision-making, with primary remote work and periodic on-site meetings, and a base salary in a broad

Qualifications

• PhD in statistics/biostatistics or related field with pharma/biotech experience.
• Significant experience providing statistical leadership for clinical programs.
• Experience supporting regulatory interactions and submissions is preferred.
• Oncology or hematology trial experience is preferred.
• Experience overseeing CROs, vendors, or external partners is required.

Responsibilities

• Serve as the biostatistics lead for one or more clinical development programs and guide study design and analysis plans.
• Represent Biostatistics on cross-functional teams and integrate statistical input into development decisions.
• Lead regulatory interactions, including briefing documents and Q&A discussions.
• Author or review statistical sections of protocols, SAPs, submissions, and papers.
• Provide interpretation of results and support data-driven program decisions.
• Identify risks and mitigation strategies; oversee external vendor statistics activities.
• Provide mentoring to statisticians and statistical programmers; promote methodological innovations.

Skills

Biostatistics leadership

Regulatory awareness

CDISC standards

SAS

R

Cross-functional communication

Strategic leadership

Education

PhD in Statistics/Biostatistics

MS in a related quantitative field

Tools

SAS

R

Job description

Sumitomo Pharma America (SMPA) is seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs. You will partner with cross-functional teams to shape design, analyses, and regulatory submissions, while mentoring statisticians and collaborating with regulatory authorities as needed.

The role emphasizes Bayesian/complex designs and quantitative decision-making, with primary remote work and periodic on-site meetings, and a base salary in a broad