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

ClinChoice

23h • Remote

About The Position

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!

Requirements

• MS or PhD in Statistics, Biostatistics, or a related field
• Strong experience in Oncology studies
• Hands-on experience writing Statistical Analysis Plans (SAPs)
• Hands-on experience writing Analysis Database Specifications
• Hands-on experience reviewing and interpreting analysis results
• SAS programming skills required (hands-on or strong working knowledge)
• Excellent written and verbal communication skills
• Experience working in a CRO and/or pharmaceutical/biotech environment

Nice To Haves

• Experience leading Phase II–III clinical trials
• Prior interaction with regulatory agencies
• Experience mentoring junior statisticians or programmers

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior