Senior Biostatistics Lead – Remote & Regulatory Strategy

Sumitomo Pharma; Santa Fe (NM); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to lead statistical aspects of one or more clinical development programs.

You will shape development plans, study designs, analyses, and regulatory submissions, while mentoring statisticians and coordinating with CROs and cross-functional teams. This senior role requires hands-on leadership in oncology or hematology programs.

Qualifications

• PhD in Statistics or Biostatistics with 5+ years in pharma/biotech OR MS with 8+ years in pharma/biotech.
• Experience providing statistical leadership for clinical development programs and trials.
• Experience supporting regulatory interactions and marketing applications preferred.
• Oncology or hematology clinical development experience preferred.
• Experience overseeing CROs, vendors, or external statistical partners required.

Responsibilities

• Serve as the biostatistics lead for one or more clinical development programs; provide strategic input on plans, study designs, and analysis strategies.
• Represent Biostatistics on cross-functional teams; ensure statistical considerations in development decisions.
• Lead statistical interactions with regulatory authorities and prepare briefing documents and responses.
• Author or oversee statistical sections of protocols, SAPs, regulatory submissions, and publications.
• Provide statistical interpretation of results and support data-driven program decisions.

Skills

Bayesian methods

SAS

R

Regulatory interactions

Leadership

Statistical programming

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

CDISC

Job description

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to lead statistical aspects of one or more clinical development programs.

You will shape development plans, study designs, analyses, and regulatory submissions, while mentoring statisticians and coordinating with CROs and cross-functional teams. This senior role requires hands-on leadership in oncology or hematology programs.