PrincipalBiostatistician

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Clinical Project Manager II 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 Immunology or any therapeutic areas 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 Required Qualifications MS or PhD in Statistics, Biostatistics, or a related field Strong experience in Immunology or any TA clinical 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 c