Principal Biostatistician, Functional Service Provider (Fsp) - R Regulatory Submission & Multiple

2 years

$131,300 – $243,900

Durham

10 Sept. 9, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences 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

Job Title:

Principal Biostatistician, Functional Service Provider (FSP) - R Regulatory Submission & Multiple Imputations
📍 Durham, North Carolina (Home-based in the U.S. or Canada)
🕒 Full-Time
📄 Job ID: R1451351
🌍 Job available in additional locations

Company Overview

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. Data Sciences Staffing Solutions (DSSS) delivers fully embedded resources through Functional Service Provider (FSP) partnerships, enabling direct collaboration with cross-functional sponsor teams from world-class pharmaceutical and biotech companies.

🌐 Learn more: https://jobs.iqvia.com

Why DSSS?

Home-based remote work opportunities
Work/life balance and flexible schedules
Collaboration with motivated, high-performance statistical and research teams
Access to technical training and tailored development curriculum
Research projects matching your unique skillset
Promising career trajectory with long-term engagements and re-deployment opportunities
Focus on advancing new therapies to market rather than project budgets and change orders
Engaging and fast-paced work environment

Job Summary

Provide comprehensive statistical support for clinical trials involving patients, focusing on regulatory submissions and multiple imputation analyses.

Key Responsibilities

Collaborate with multidisciplinary teams to establish project objectives and timelines
Write statistical sections for clinical trial protocols in consultation with internal and external experts
Develop statistical analysis plans (SAPs)
Monitor internal and CRO project activities, including timelines, deliverables, and resources
Collaborate with Data Management, Clinical Development, and Clinical Operations providing statistical expertise
Contribute to clinical study reports and regulatory documents such as DSURs and Briefing Documents
Guide and supervise programmers in authoring dataset specifications and programming of tables, listings, and figures
Interpret study results and review reports for accuracy
Support exploratory analyses and medical affairs publications
Participate in pre-IND and NDA activities
Engage in other activities and meetings to support Biostatistics and Development Teams as required

Minimum Qualifications

PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience
OR MS in Statistics, Biostatistics, or related field with 7+ years of industry experience
Minimum 3 years of experience with Phase 2/3 clinical trials
Demonstrated ability to independently manage projects and make decisions
Effective communication skills and ability to manage programmers constructively
Proficiency in R for efficacy and safety analyses and data validation
Understanding of ICH GCP, ICH E9, and general industry practices and standards
At least 2 years supporting multiple imputation analyses
Experience with CDISC standards including SDTM, ADaM, and CDASH

Desired Experience

Interaction experience with regulators, including Advisory Committee meetings
2+ years of experience in Immunology therapeutic area and regulatory submissions

Compensation & Benefits

💰 Annual Salary Range:
$131,300 – $243,900 (varies by qualifications, experience, location, and schedule)

Additional benefits may include:

Incentive plans and bonuses
Health and welfare benefits

Work Environment

🏠 Home-based (Remote work) within the U.S. or Canada

Equal Employment Opportunity

IQVIA is an equal opportunity employer. All qualified applicants receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other protected status.

🔗 EEO Policy

How to Apply

🔗 Apply Now

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Principal Biostatistician, Functional Service Provider (Fsp) - R Regulatory Submission & Multiple

Job Description

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