Biostatistics Lead - Clinical Development (Remote)

Sumitomo Pharma; Frankfort (KY); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America is seeking an Associate Director of Biostatistics to provide strategic statistical leadership across clinical development programs. You will design studies, guide regulatory submissions, and collaborate with cross‑functional teams to ensure rigorous statistics and feasible execution.

The role emphasizes oversight of statistical plans, interpretation of results, and mentoring of statisticians, with a focus on Bayesian and adaptive methods where appropriate.

Qualifications

• PhD in Statistics or Biostatistics with 5+ years of pharma/biotech experience.
• Experience leading statistical sections for protocols and regulatory submissions.
• Strong communication to senior leadership and cross-functional teams.
• Experience overseeing CROs or external vendors.

Responsibilities

• Lead statistical leadership for one or more clinical development programs.
• Represent Biostatistics on cross-functional teams and influence decisions.
• Lead regulatory interactions, briefing documents, and Q&A discussions.
• Author or review statistical sections of SAPs, protocols, submissions.
• Provide statistical interpretation of results and data-driven decisions.
• Mentor statisticians and programmers; oversee external outputs.
• Apply Bayesian methods, adaptive designs, and quantitative decision-making.
• Contribute to governance, standards, and capability development.

Skills

Biostatistics leadership

Clinical statistics

SAS

R programming

Regulatory experience

Cross-functional collaboration

Education

PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma America is seeking an Associate Director of Biostatistics to provide strategic statistical leadership across clinical development programs. You will design studies, guide regulatory submissions, and collaborate with cross‑functional teams to ensure rigorous statistics and feasible execution.

The role emphasizes oversight of statistical plans, interpretation of results, and mentoring of statisticians, with a focus on Bayesian and adaptive methods where appropriate.