Principal Biostatistician for inhouse project (Permanent role)

ClinChoice

15d•Remote

About The Position

ClinChoice is 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. The Principal Biostatistician will lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas. This is a permanent role within an in-house team supporting projects across a diverse client portfolio.

Requirements

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)
Hands-on experience writing Analysis Database Specifications
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 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), and 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