Remote Associate Director, Biostatistics — Clinical Lead

Sumitomo Pharma; Trenton (NJ); Remote; USD 166,000 - 207,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Paid time off and holidays

Job summary

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across clinical development programs. You will design studies, guide regulatory interactions, and collaborate with cross-functional teams to ensure rigorous, regulatorily aligned statistical deliverables.

Responsibilities include leading statistical inputs, reviewing SAPs and protocols, and mentoring statisticians while exploring Bayesian and adaptive methods where appropriate.

Qualifications

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

Responsibilities

• Lead statistical input into development plans and study designs.
• Represent Biostatistics on cross-functional teams and ensure statistical considerations.
• Lead regulatory interactions and briefing documents.
• Prepare statistical sections of protocols and SAPs.
• Provide statistical interpretation and support data-driven decisions.
• Identify risks and mitigation strategies.
• Oversee CRO and vendor statistical activities.
• Provide mentorship to statisticians and programmers.
• Evaluate Bayesian and adaptive designs when appropriate.
• Contribute to governance and capability development.

Skills

Biostatistics leadership

Clinical trial design

SAS

R

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

PhD in Statistics

MS in related field

Tools

SAS

R

CDISC

Job description

Sumitomo Pharma America is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across clinical development programs. You will design studies, guide regulatory interactions, and collaborate with cross-functional teams to ensure rigorous, regulatorily aligned statistical deliverables.

Responsibilities include leading statistical inputs, reviewing SAPs and protocols, and mentoring statisticians while exploring Bayesian and adaptive methods where appropriate.