Remote Associate Director, Biostatistics – Clinical Leader

Sumitomo Pharma; Olympia (WA); Remote; USD 166,000 - 207,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Sumitomo Pharma America is seeking an Associate Director of Biostatistics to lead statistics across one or more clinical programs. You will shape study design, analysis plans, and regulatory submissions, and collaborate with cross-functional teams to align statistical strategies with program goals.

The role requires a PhD (or MS with extensive pharma experience), strong SAS/R skills, and a track record of regulatory interactions in oncology/hematology.

Qualifications

• PhD in Statistics or Biostatistics with relevant pharma/biotech experience.
• Significant leadership of clinical development programs and trials.
• Experience supporting regulatory interactions and submissions.
• Oncology or hematology development preferred.

Responsibilities

• Serve as biostatistics lead for clinical programs and study designs.
• Represent Biostatistics on cross-functional teams and regulatory interactions.
• Lead statistical input for briefing documents and regulatory questions.
• Oversee SAPs, protocols, and regulatory submissions.
• Provide statistical interpretation and data-driven program decisions.
• Manage CROs and external stats vendors; ensure timelines and quality.
• Mentor statisticians and programmers; apply innovative methods.

Skills

Biostatistics leadership

Clinical trials

SAS and R

Regulatory guidance

Bayesian methods

Cross-functional leadership

Education

PhD in Statistics or Biostatistics

MS with 8+ years experience

Tools

SAS

R

Job description

Sumitomo Pharma America is seeking an Associate Director of Biostatistics to lead statistics across one or more clinical programs. You will shape study design, analysis plans, and regulatory submissions, and collaborate with cross-functional teams to align statistical strategies with program goals.

The role requires a PhD (or MS with extensive pharma experience), strong SAS/R skills, and a track record of regulatory interactions in oncology/hematology.