Senior Biostatistics Lead – Clinical Development (Remote)

Sumitomo Pharma America, Inc.; United States; Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. seeks an Associate Director of Biostatistics to lead statistical strategy across one or more clinical programs.

You will partner with cross-functional teams, shape development plans, study designs, analyses, and regulatory submissions, and mentor junior statisticians. The role emphasizes rigorous statistical thinking, collaboration with regulators, and innovative methods in oncology and related areas.

Qualifications

• Broad knowledge of statistical principles and drug development.
• Experience with regulatory guidance and health authorities.
• Experience with CDISC standards and complex trial designs preferred.
• Ability to communicate statistics clearly to diverse audiences.

Responsibilities

• Lead input into development plans, study designs, and analysis strategies.
• Represent Biostatistics on cross-functional teams and influence decisions.
• Lead regulatory interactions and prepare responses for questions.
• Oversee protocols, SAPs, submissions, publications and related docs.
• Provide interpretation of results and support data-driven decisions.
• Identify risks and mitigation strategies across statistics and regulatory domains.
• Oversee CROs and external vendor statistics activities.
• Coach and mentor statisticians and programmers.
• Evaluate Bayesian/adaptive methods and innovative designs when appropriate.
• Contribute to governance and capability development.

Skills

Biostatistics leadership

Clinical development

Regulatory interactions

SAS and R

Study design

Bayesian methods

Cross-functional collaboration

Mentorship

Education

PhD in Statistics/Biostatistics or related field

MS with 8+ years in pharma/biotech

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. seeks an Associate Director of Biostatistics to lead statistical strategy across one or more clinical programs.

You will partner with cross-functional teams, shape development plans, study designs, analyses, and regulatory submissions, and mentor junior statisticians. The role emphasizes rigorous statistical thinking, collaboration with regulators, and innovative methods in oncology and related areas.