Lead Biostatistician, Oncology - Remote

Sumitomo Pharma America, Inc.; United States; A distancia; USD 128.000 - 159.000; Jornada completa

Descripción de la vacante

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs, from protocol through regulatory submission.

You will serve as lead statistician on studies and partner with Clinical Development, Data Management, Regulatory Affairs, and external vendors to ensure quality deliverables. Ideal candidates have an MS/PhD in statistics or biostatistics and strong SAS experience, with regulatory knowledge and cross-functional

Formación

• MS or PhD in Statistics/Biostatistics or related field.
• Experience leading oncology clinical studies.
• Familiarity with FDA/EMA guidelines.
• Proficiency in SAS; R knowledge desirable.
• Strong collaboration and communication skills.

Responsabilidades

• Lead statistician for one or more oncology clinical studies.
• Contribute to study design, endpoints, sample size, randomization, and analysis strategy.
• Prepare and review SAPs and CSRs; contribute to regulatory submissions.
• Collaborate with CROs and external vendors to ensure timely deliverables.
• Provide mentoring to junior statisticians and promote best practices.

Conocimientos

Statistical leadership

Regulatory knowledge

Communication skills

Team mentoring

Clinical trial methodology

Educación

MS in Statistics/Biostatistics or PhD in Statistics/Biostatistics

Herramientas

SAS programming

R

CDISC SDTM/ADaM

Descripción del empleo

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs, from protocol through regulatory submission.

You will serve as lead statistician on studies and partner with Clinical Development, Data Management, Regulatory Affairs, and external vendors to ensure quality deliverables. Ideal candidates have an MS/PhD in statistics or biostatistics and strong SAS experience, with regulatory knowledge and cross-functional