Remote Oncology Biostatistics Lead

Sumitomo Pharma; Helena (MT); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

401(k)

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Flexible time off

Holidays

Job summary

Sumitomo Pharma America (SMPA) is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs, from protocol through regulatory submission. You will lead study design, SAPs, analyses, and reporting, collaborating with cross-functional teams and CROs to ensure high-quality, timely deliverables.

The role emphasizes expertise in CDISC SDTM/ADaM, FDA/EMA guidelines, and effective cross-functional communication in a remote work setting.

Qualifications

• MS or PhD in Statistics/Biostatistics or related quantitative discipline with 4+ years of experience.
• Strong understanding of statistical principles and clinical trial methodology.
• Familiarity with regulatory guidelines (FDA/EMA) and CDISC standards.
• Experience designing, analyzing, and reporting clinical trials; CRO exposure is a plus.
• Proficiency in SAS; R experience desirable; ability to communicate complex statistics clearly.

Responsibilities

• Serve as 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 TLF development.
• Ensure quality and accuracy of statistical deliverables; interpret results for teams.
• Support regulatory submissions and interactions with health authorities.
• Collaborate with CROs and internal teams to deliver timely results.

Skills

Statistics

Biostatistics

Study design

SAS programming

R programming

Regulatory knowledge

Cross-functional teamwork

Clinical trial analysis

Data interpretation

Communication skills

Education

MS/PhD in Statistics or Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Sumitomo Pharma America (SMPA) is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs, from protocol through regulatory submission. You will lead study design, SAPs, analyses, and reporting, collaborating with cross-functional teams and CROs to ensure high-quality, timely deliverables.

The role emphasizes expertise in CDISC SDTM/ADaM, FDA/EMA guidelines, and effective cross-functional communication in a remote work setting.