Remote Associate Director, Biostatistics

Sumitomo Pharma; Augusta (ME); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to serve as the statistical lead for one or more clinical development programs.

You will provide strategic statistical leadership across development planning, study design, analysis, and regulatory submissions. The role requires a PhD in Statistics or Biostatistics with 5+ years in pharma, expertise in SAS and R, and strong collaboration with cross functional teams.

Qualifications

• PhD in Statistics or Biostatistics with at least 5 years in pharma/biotech.
• Experience providing statistical leadership for clinical development programs.
• Experience supporting regulatory interactions and submissions.
• Oncology or hematology clinical development experience preferred.
• Oversight of CROs/vendors and external statistical partners required.

Responsibilities

• Serve as biostatistics lead for one or more programs with strategic input on plans and analysis.
• Represent Biostatistics on cross-functional teams and influence development decisions.
• Lead statistical interactions with regulatory authorities and prepare responses to questions.
• Author/review statistical sections of protocols, SAPs, submissions, and publications.
• Provide statistical interpretation of results and support data-driven decisions.
• Identify risks and mitigate with practical strategies.
• Oversee CRO/vendor statistical activities and timelines.
• Provide mentorship to statisticians and programmers.
• Evaluate innovative methods including Bayesian/adaptive designs when appropriate.
• Contribute to governance and capability development.

Skills

Statistical leadership

Clinical development

Regulatory interactions

SAS

R

Communication

Cross-functional collaboration

Project management

Bayesian methods

Regulatory knowledge

Education

PhD in Statistics

MS in Statistics

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to serve as the statistical lead for one or more clinical development programs.

You will provide strategic statistical leadership across development planning, study design, analysis, and regulatory submissions. The role requires a PhD in Statistics or Biostatistics with 5+ years in pharma, expertise in SAS and R, and strong collaboration with cross functional teams.