Lead Biostatistician, Oncology (Remote)

Sumitomo Pharma; Juneau (AK); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma America (SMPA) seeks a Manager, Biostatistics (Oncology) to lead statistical activities across oncology trials, from protocol input to CSR and regulatory submissions. Remote work with periodic on-site meetings.

The role requires an MS or PhD in statistics/biostatistics, strong regulatory knowledge, SAS proficiency, and experience with CDISC standards. Oncology experience and CRO collaboration are preferred.

Qualifications

• MS and 4+ years in Statistics or Biostatistics, or a PhD in the field.
• Strong understanding of statistical principles and trial methodology.
• Experience with regulatory guidelines (FDA/EMA/PMDA) and ICH.
• Proficiency in SAS; knowledge of R is desirable.
• Experience in oncology clinical development and CRO experience.
• Experience contributing to protocols, SAPs, CSRs, and regulatory submissions.

Responsibilities

• Serve as lead statistician for oncology studies.
• Provide input on study design, endpoints, sample size, randomization, analysis strategy.
• Contribute to protocol development and SAP creation.
• Author/review SAPs and CSR documents.
• Collaborate with programming to develop analysis datasets, tables, listings, figures.
• Review outputs for quality, consistency, and accuracy.
• Interpret results and communicate to cross-functional teams.
• Support regulatory submissions and responses to authorities.
• Coordinate with CRO statisticians and vendors.

Skills

Statistical principles

Clinical trial methodology

SAS programming

R (desirable)

Regulatory guidelines (FDA/EMA/PMDA)

CDISC standards

Cross-functional teamwork

Protoco ls/SAPs/CSRs

CRO/vendor collaboration

Oncology experience

Education

MS in Statistics/Biostatistics or related field

PhD in Statistics/Biostatistics or related field

Tools

CDISC SDTM/ADaM

Job description

Sumitomo Pharma America (SMPA) seeks a Manager, Biostatistics (Oncology) to lead statistical activities across oncology trials, from protocol input to CSR and regulatory submissions. Remote work with periodic on-site meetings.

The role requires an MS or PhD in statistics/biostatistics, strong regulatory knowledge, SAS proficiency, and experience with CDISC standards. Oncology experience and CRO collaboration are preferred.