Senior Biostatistics Lead, Oncology Trials

Summit Therapeutics Inc.; Miami (FL); On-site; USD 174,000 - 203,000; Full time

Job summary

Summit Therapeutics Inc. seeks a senior biostatistician to lead statistical strategy and analyses for oncology trials. You will partner with clinical science, regulatory, and other teams to design studies, prepare submissions, and ensure rigorous interpretation of data.

You will develop department policies, coordinate with CROs, and oversee data quality, ADaM programming, and regulatory responses. A Ph.D. or equivalent with biopharma leadership is required.

Qualifications

• Ph.D. in Statistics or Biostatistics with 6+ years in biopharmaceuticals.
• Strong proficiency in SAS and R for analyses and reporting.
• Working knowledge of ICH, FDA and GCP regulations.

Responsibilities

• Provide technical leadership and statistical support for oncology trials.
• Lead development of SAPs and data presentation plans.
• Review data, perform analyses, and interpret results for reports.
• Prepare regulatory sections and respond to inquiries during submissions.
• Collaborate with CROs, data management, and clinical teams.

Skills

Biostatistics leadership

SAS

R

Statistical analysis

Regulatory communication

Education

Ph.D. in Statistics/Biostatistics

MS in related discipline

Tools

SAS

R

Job description

Summit Therapeutics Inc. seeks a senior biostatistician to lead statistical strategy and analyses for oncology trials. You will partner with clinical science, regulatory, and other teams to design studies, prepare submissions, and ensure rigorous interpretation of data.

You will develop department policies, coordinate with CROs, and oversee data quality, ADaM programming, and regulatory responses. A Ph.D. or equivalent with biopharma leadership is required.