Principal Biostatistician – Inhouse Project

ClinChoice

. Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas .

Posted 11/4/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and support for clinical studies, particularly in Immunology and Oncology, with a strong focus on regulatory compliance and collaboration across multidisciplinary teams.

Highest-signal resume keywords

Statistical Analysis Plans (SAPs)SAS Programming SkillsClinical Trial LeadershipRegulatory ComplianceMentoring Junior Statisticians

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiostatisticsStatistical Analysis Plans (SAPs)Analysis Database Specifications (ADS)Reviewing Analysis ResultsStatistical Strategy DevelopmentFDA RegulationsICH GuidelinesGCP CompliancePhase II–III Clinical TrialsOncology Studies

Soft Skills

Excellent Written CommunicationExcellent Verbal Communication

Certifications & Qualifications

MS or PhD in StatisticsMS or PhD in Biostatistics

Industry Keywords

CRO ExperiencePharmaceutical EnvironmentBiotech EnvironmentRegulatory Agency Interaction

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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 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 Clinical, Programming, Data Management, and Regulatory teams
Provide guidance and oversight to statistical programmers as needed
Communicate statistical concepts, results, and risks to technical and non-technical stakeholders
Ensure adherence to FDA, ICH, GCP, and company SOPs

Requirements

What you’ll need

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

Benefits

Comp & perks

Professional growth opportunities
Fulfilling and rewarding career
Continuous training and development
Equal opportunity and diversity and inclusivity culture