Principal Biostatistician

4w1 month ago

ClinChoice

US · Full-time · $140,000 – $170,000

About this role

ClinChoice is seeking a highly skilled Principal Biostatistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise and the ability to independently lead projects while collaborating closely with cross-functional teams.

The Principal Biostatistician will provide statistical support primarily within Immunology or any therapeutic area. They will act as lead statistician, authoring Statistical Analysis Plans and Analysis Database Specifications while ensuring accuracy and regulatory compliance.

Join our quality-driven 'one-team' culture at a global full-service CRO. You will collaborate with Clinical, Programming, Data Management, and Regulatory teams, providing guidance to statistical programmers.

You can be part of making a difference in peoples' lives while experiencing a fulfilling and rewarding career. ClinChoice is committed to professional growth in a supportive environment.

Requirements

MS or PhD in Statistics, Biostatistics, or a related field
Strong experience in Immunology or any therapeutic area clinical studies
Hands-on experience writing Statistical Analysis Plans (SAPs) and Analysis Database Specifications
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
Experience leading Phase II–III clinical trials (preferred)
Prior interaction with regulatory agencies (preferred)

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) and Analysis Database Specifications (ADS)
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

Benefits

Professional growth opportunities in a quality-driven one-team culture
The chance to make a difference in peoples' lives through meaningful clinical research
A fulfilling and rewarding career with a global full-service CRO