Senior Biostatistics Leader - Remote Clinical Development

Sumitomo Pharma; Salem (OR); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. is seeking an Associate Director of Biostatistics to lead statistical strategy across one or more clinical development programs and coordinate with cross-functional teams.

The role includes planning, design, analysis, regulatory submissions, and external collaborations. The position requires advanced degrees in statistics with strong regulatory experience, expertise in SAS/R, and a track record in oncology or related areas.

Qualifications

• PhD in Statistics, Biostatistics, or related quantitative discipline with required years of experience.
• Experience providing statistical leadership for clinical development programs and trials.
• Experience supporting regulatory interactions and applications is preferred.

Responsibilities

• Serve as biostatistics lead for one or more clinical development programs and provide input on plans, designs, decisions and analysis strategies.
• Represent Biostatistics on cross-functional teams and ensure statistical considerations are included in development decisions.
• Lead statistical interactions with regulatory authorities and prepare briefing documents and responses.
• Author or oversee statistical sections of protocols, SAPs, submissions and publications.
• Provide statistical interpretation of results and support data‑driven program decisions.
• Identify risks and mitigation strategies; oversee CRO and external supplier statistics work.
• Provide technical leadership and mentorship to statisticians and programmers.
• Evaluate innovative statistical methods when appropriate and contribute to governance and standards.

Skills

Statistical leadership

Regulatory interactions

SAS and R

Bayesian methods

Clinical trial design

Cross-functional collaboration

Regulatory guidance knowledge

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics with 8+ years

Tools

SAS

R

Job description

Sumitomo Pharma Co., Ltd. is seeking an Associate Director of Biostatistics to lead statistical strategy across one or more clinical development programs and coordinate with cross-functional teams.

The role includes planning, design, analysis, regulatory submissions, and external collaborations. The position requires advanced degrees in statistics with strong regulatory experience, expertise in SAS/R, and a track record in oncology or related areas.