ClinChoice · 2 days ago
Senior/Principal Statistician with focus on Immunology studies_FTE-Remote
United States
Full-time
Remote
Senior Level, Lead/StaffClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking a highly skilled Senior or Principal Statistician to support and lead statistical activities for clinical trials, particularly focusing on Immunology studies.
BiotechnologyConsultingHealth CarePharmaceutical
Responsibilities
Lead and provide statistical support for clinical studies, primarily within Immunology 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
Qualification
Required
MS or PhD in Statistics, Biostatistics, or a related field
Strong experience in Immunology clinical studies (required)
Proven ability to lead projects and studies independently
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
Experience leading Phase II–III clinical trials
Prior interaction with regulatory agencies
Experience mentoring junior statisticians or programmers
Company
ClinChoice
ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices.
Founded in 1995
1001-5000 employees
H1B Sponsorship
ClinChoice has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (28)
2023 (21)
2022 (25)
2021 (35)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$212MKey Investors
Legend CapitalGoldman Sachs,Lilly Asia VenturesGoldman Sachs
2022-07-04Series E· $150M
2019-10-25Series D· $62M
2019-05-01Series C
Leadership Team
John Balian, MD
Chief Executive Officer
Recent News
2025-11-18
2023-07-18
Bloomberg.com
2023-07-07
Company data provided by crunchbase