Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.

We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

• Lead and provide statistical support for clinical studies, primarily within Oncology

• Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables

• Author and review key statistical documents, including:

• Statistical Analysis Plans (SAPs)

• Analysis Database Specifications (ADS)

• Statistical sections of clinical study reports

• Review and interpret analysis outputs, ensuring 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, results, and risks clearly to both technical and non-technical stakeholders

• Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs

• MS or PhD in Statistics, Biostatistics, or a related field

• Strong experience in Oncology studies

• Hands-on experience writing:

• Statistical Analysis Plans (SAPs)

• Analysis Database Specifications

• Reviewing and interpreting analysis results

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