Lead Principal Biostatistician – Oncology (Remote)

clinchoice; United States; Remote; USD 140,000 - 200,000; Full time

Job summary

ClinChoice is seeking a Principal Statistician to lead statistical activities for oncology clinical trials within a global CRO framework. The role expects hands‑on expertise, strong communication, and the ability to independently guide projects while coordinating with cross‑functional teams.

The successful candidate will author SAPs, ADS, and statistical sections of reports, ensure regulatory compliance, and mentor junior statisticians.

Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field.
• Experience in Oncology studies.
• Hands‑on experience writing SAPs/ADS and reviewing analysis results.
• SAS programming skills required or strong working knowledge.

Responsibilities

• Lead statistical activities for clinical studies, primarily Oncology.
• Act as lead statistician on assigned studies, overseeing strategy and deliverables.
• Author and review SAPs, ADS, and statistical sections of clinical study reports.
• Review and interpret analysis outputs for accuracy, quality and regulatory compliance.
• Collaborate with cross‑functional teams including Clinical, Programming, Data Management and Regulatory.
• Provide guidance and oversight to statistical programmers as needed.
• Communicate statistical concepts and results clearly to technical and non‑technical stakeholders.
• Ensure adherence to FDA, ICH, GCP and company SOPs.

Skills

Statistical analysis

Project leadership

Communication

Mentoring

Scientific writing

Education

MS/PhD in Statistics

Tools

SAS

Job description

ClinChoice is seeking a Principal Statistician to lead statistical activities for oncology clinical trials within a global CRO framework. The role expects hands‑on expertise, strong communication, and the ability to independently guide projects while coordinating with cross‑functional teams.

The successful candidate will author SAPs, ADS, and statistical sections of reports, ensure regulatory compliance, and mentor junior statisticians.