Senior Biostatistics Lead - Oncology/Regulatory Strategy (Remote)

Sumitomo Pharma; Phoenix (AZ); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America is seeking an Associate Director, Biostatistics for a remote-friendly, full-time role. You will serve as the statistical lead for clinical development programs, shaping designs, analyses, and regulatory submissions while guiding cross-functional teams.

You will provide strategic leadership, apply Bayesian and adaptive methods when appropriate, and mentor statisticians and programmers within a fast-paced environment.

Qualifications

• PhD or MS with extensive pharmaceutical experience.
• Significant leadership of clinical development programs.
• Experience with regulatory interactions strongly preferred.

Responsibilities

• Lead statistical input into development plans and study designs.
• Represent Biostatistics on cross-functional teams.
• Lead regulatory interactions and prepare statistical sections.
• Provide statistical interpretation and decision-making.
• Oversee CROs and external vendors for statistics work.
• Mentor statisticians and programmers.

Skills

Statistical leadership

Cross-functional influence

Regulatory communication

SAS

R

Bayesian methods

Clinical trial design

Quantitative decision-making

Education

PhD in Statistics/Biostatistics or related, 5+ years

MS in Statistics/Biostatistics, 8+ years

Tools

SAS

R

Job description

Sumitomo Pharma America is seeking an Associate Director, Biostatistics for a remote-friendly, full-time role. You will serve as the statistical lead for clinical development programs, shaping designs, analyses, and regulatory submissions while guiding cross-functional teams.

You will provide strategic leadership, apply Bayesian and adaptive methods when appropriate, and mentor statisticians and programmers within a fast-paced environment.