Senior Biostatistics Lead - Remote Trials

Sumitomo Pharma; Nashville (TN); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking an Associate Director, Biostatistics to serve as the statistical lead for clinical development programs. The role focuses on study design, data analysis, regulatory submissions, and external collaborations, driving scientifically rigorous strategies.

The position requires leadership in Bayesian/adaptive methods, mentorship of statisticians, and effective communication with cross‑functional teams and senior leadership.

Qualifications

• PhD or MS with substantial pharma/biotech clinical development experience.
• Experience leading statistical activities across clinical programs and trials.
• Experience with regulatory interactions and submissions is strongly preferred.

Responsibilities

• Serve as statistical lead for one or more clinical programs and influence design and analysis strategies.
• Lead regulatory interactions and preparation of briefing documents and responses.
• Oversee CROs and external vendors; provide mentorship to statisticians.

Skills

Statistical leadership

Regulatory knowledge

Cross‑functional collaboration

Communication to audiences

Decision‑making

Education

PhD in Statistics/Biostatistics

MS with 8+ years in pharma/biotech

Tools

SAS

R

CDISC

Job description

Sumitomo Pharma America (SMPA) is seeking an Associate Director, Biostatistics to serve as the statistical lead for clinical development programs. The role focuses on study design, data analysis, regulatory submissions, and external collaborations, driving scientifically rigorous strategies.

The position requires leadership in Bayesian/adaptive methods, mentorship of statisticians, and effective communication with cross‑functional teams and senior leadership.