About this role
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!
Key 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
-
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
-
Required Qualifications
-
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
-
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
-
Preferred Qualifications
-
Experience leading Phase II–III clinical trials
-
Prior interaction with regulatory agencies
-
Experience mentoring junior statisticians or programmers