Senior Biostatistics Strategy Lead (Remote)

Sumitomo Pharma; Providence (RI); Remote; USD 166,000 - 207,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Paid time off

Job summary

Sumitomo Pharma Co., Ltd. is seeking an Associate Director, Biostatistics to lead statistical strategy across one or more clinical programs. You will design studies, shape development plans, and guide regulatory submissions, while ensuring rigorous methods and clear communication with stakeholders.

You will collaborate with cross-functional teams, mentor statisticians, and oversee CRO activities. Oncology/hematology experience and FDA/EMA interactions are preferred.

Qualifications

• PhD or MS with multiple years in pharmaceutical/biotech industry.
• Significant experience leading clinical development programs.
• Experience with regulatory interactions and submissions is preferred.
• Oncology or hematology development experience is a plus.
• Experience supervising CROs and external statist partners.

Responsibilities

• Lead statistical input for development plans, study designs, decisions and analysis strategies.
• Represent Biostatistics on cross-functional teams and governance forums.
• Lead regulatory interactions, briefing documents, and responses to questions.
• Author and review SAPs, protocols and regulatory submissions.
• Interpret study results and support data-driven program decisions.
• Mentor statisticians and statistical programmers.
• Apply Bayesian/adaptive methods where appropriate.
• Oversee CRO/vendor statistical activities and timelines.
• Contribute to standards and governance in Statistics.

Skills

Biostatistics leadership

Cross-functional collaboration

Regulatory communication

Communication to leadership

Statistical analysis interpretation

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics with significant pharma experience

Tools

SAS

R

CDISC

Job description

Sumitomo Pharma Co., Ltd. is seeking an Associate Director, Biostatistics to lead statistical strategy across one or more clinical programs. You will design studies, shape development plans, and guide regulatory submissions, while ensuring rigorous methods and clear communication with stakeholders.

You will collaborate with cross-functional teams, mentor statisticians, and oversee CRO activities. Oncology/hematology experience and FDA/EMA interactions are preferred.