Associate Director, Biostatistics — Remote

Sumitomo Pharma; Lansing (MI); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America (SMPA) seeks an Associate Director, Biostatistics to lead statistics for one or more clinical development programs, shaping study designs, analysis plans, regulatory submissions, and data‑driven decisions through cross‑functional collaboration.

The role requires a PhD in Statistics or Biostatistics (or MS with substantial pharma experience), expertise in SAS and R, and the ability to communicate complex concepts to both technical and non‑technical audiences.

Qualifications

• PhD in Statistics, Biostatistics, or related field with ≥5 years in pharma/biotech.
• Significant experience leading clinical development programs and trials.
• Experience supporting regulatory interactions and submissions preferred.
• Oncology or hematology development experience preferred.
• Experience overseeing CROs, vendors, or external statistics partners required.

Responsibilities

• Lead statistical input into development plans, designs, and analysis strategies.
• Represent Biostatistics on cross-functional program teams and decisions.
• Lead regulatory interactions including briefing documents and responses.
• Author/statistical sections of protocols, SAPs, submissions.
• Provide interpretation, communicate risk-benefit, support decisions.
• Identify risks and mitigation strategies.
• Oversee CROs and external vendors, ensure timelines and quality.
• Provide mentorship to statisticians and programmers.
• Apply innovative methods when appropriate.
• Contribute to governance and capability development.

Skills

Biostatistics leadership

Cross-functional leadership

Bayesian methods

Adaptive designs

Data analysis

Statistical programming

Communication

ICH/FDA knowledge

Education

PhD in Statistics/Biostatistics

MS with 8+ years pharma

Tools

SAS

R

Job description

Sumitomo Pharma America (SMPA) seeks an Associate Director, Biostatistics to lead statistics for one or more clinical development programs, shaping study designs, analysis plans, regulatory submissions, and data‑driven decisions through cross‑functional collaboration.

The role requires a PhD in Statistics or Biostatistics (or MS with substantial pharma experience), expertise in SAS and R, and the ability to communicate complex concepts to both technical and non‑technical audiences.