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Principal Biostatistician

7-9 years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Principal Biostatistician (Remote – United States)

Location: United States (Remote)
Company: ICON plc
Work Mode: Fully Remote
Preferred Time Zone: Pacific Time (flexible)
Job ID: JR130280


Job Summary

ICON plc, a global leader in clinical research and healthcare intelligence, is hiring a Principal Biostatistician to lead the statistical direction for complex Phase I–III oncology trials. This is a remote opportunity for an experienced biostatistics professional with strong client-facing and regulatory experience to drive trial success through robust statistical methodologies.


Key Responsibilities

  • Serve as lead biostatistician on complex Phase I–III oncology clinical trials

  • Review and approve SAPs, protocols, and statistical content in clinical reports

  • Provide statistical oversight and support to regulatory submissions (e.g., NDAs)

  • Program statistical analyses using SAS and/or R

  • Participate in bid defenses and client presentations

  • Mentor junior statisticians and contribute to internal process improvements

  • Lead or participate in cross-functional initiatives to refine biostatistics practices


Required Skills & Qualifications

  • Master’s (with 9+ years) or PhD (with 7+ years) in Biostatistics, Statistics, or related field

  • Extensive experience in oncology trials (Phase I–III), including leadership and client management

  • Strong understanding of regulatory expectations (NDA support, FDA interactions)

  • Proficiency in SAS and/or R for inferential statistical programming

  • Proven ability to lead statistical planning across multiple studies

  • Excellent written and verbal communication skills

  • Clinical Research Organization (CRO) experience preferred

  • Strong project and time management skills


Perks & Benefits

  • Competitive base salary (not disclosed)

  • Generous annual leave entitlements

  • Flexible health insurance options (individual and family coverage)

  • Competitive retirement planning programs

  • Global Employee Assistance Programme (LifeWorks)

  • Life assurance

  • Country-specific optional benefits (childcare vouchers, gym discounts, wellness perks, travel subsidies, etc.)


Company Description

ICON plc is a global provider of outsourced development and healthcare intelligence services to pharmaceutical, biotechnology, and medical device industries. With a focus on innovation, integrity, and inclusion, ICON delivers high-quality solutions that support every stage of clinical development.


Work Mode

Remote – United States
Preferred availability during Pacific Time business hours.


Call-to-Action

Shape the future of oncology research with ICON. Apply today to become a Principal Biostatistician and lead global clinical studies with impact and innovation.