Senior Biostatistics Lead – Remote (Oncology)

Sumitomo Pharma; Cheyenne (WY); Teletrabalho; USD 166 000 - 207 000; Tempo integral

Resumo da oferta

Sumitomo Pharma America (SMPA) 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, data analysis and regulatory submissions, partnering with cross-functional leaders to ensure rigorous and feasible statistical approaches.

The role emphasizes oversight of CROs, mentorship of statisticians, and exploration of advanced methods

Qualificações

• PhD in Statistics or Biostatistics with 5+ years in pharma/biotech.
• MS with 8+ years in pharma/biotech acceptable.
• Experience providing statistical leadership for clinical development programs.
• Experience supporting regulatory interactions is preferred.
• Oncology or hematology experience preferred.
• Experience overseeing CROs or external statistical partners.

Responsabilidades

• Provide strategic statistical leadership for one or more clinical development programs and study designs.
• Lead regulatory interactions, including briefing documents and responses to questions.
• Author and review statistical sections of protocols, SAPs, and regulatory submissions.
• Mentor statisticians and statistical programmers and oversee CRO activities.

Conhecimentos

SAS

R

Bayesian methods

Adaptive trial design

Regulatory experience

Leadership

Formação académica

PhD in Statistics/Biostatistics

MS in Statistics

Ferramentas

CDISC

Descrição da oferta de emprego

Sumitomo Pharma America (SMPA) 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, data analysis and regulatory submissions, partnering with cross-functional leaders to ensure rigorous and feasible statistical approaches.

The role emphasizes oversight of CROs, mentorship of statisticians, and exploration of advanced methods