Senior Biostatistics Leader — Remote Oncology Trials

Sumitomo Pharma; Columbus (OH); Remote; USD 166,000 - 207,000; Full time

Benefits offered by this job

Health insurance

Job summary

Sumitomo Pharma seeks an Associate Director of Biostatistics to serve as the statistical lead across one or more clinical development programs. You will partner with cross-functional teams to ensure rigorous statistical strategies and regulatory-compliant deliverables.

Responsibilities include authoring statistical sections, leading regulatory discussions, mentoring statisticians, and guiding innovative methods such as Bayesian approaches and adaptive designs. This role is remote in the U.S.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 5+ years in pharma/biotech.
• MS with 8+ years of relevant pharma/biotech experience.
• Experience leading clinical development programs and trials.
• Experience supporting regulatory interactions and filings.
• Oncology or hematology experience preferred.

Responsibilities

• Lead statistical input for one or more clinical development programs.
• Represent Biostatistics on cross-functional teams and decision meetings.
• Lead regulatory interactions, briefing documents, and responses.
• Author or oversee SMA/protocols/SAps and regulatory submissions.
• Provide statistical interpretation and data-driven program decisions.
• Oversee CRO and external vendor statistical activities.
• Mentor statisticians and programmers; drive capability development.
• Apply Bayesian/adaptive designs and quantitative decision methods.

Skills

Biostatistics leadership

Regulatory knowledge

CDISC standards

Bayesian methods

SAS and R proficiency

Stakeholder communication

Education

PhD in Statistics/Biostatistics

MS with 8+ years pharma/biotech

Tools

SAS

R

Job description

Sumitomo Pharma seeks an Associate Director of Biostatistics to serve as the statistical lead across one or more clinical development programs. You will partner with cross-functional teams to ensure rigorous statistical strategies and regulatory-compliant deliverables.

Responsibilities include authoring statistical sections, leading regulatory discussions, mentoring statisticians, and guiding innovative methods such as Bayesian approaches and adaptive designs. This role is remote in the U.S.