Senior Biostatistician (Functional Service Provider - Fsp)

1 years

$122,800 – $233,400

North Carolina

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:

Senior Biostatistician (Functional Service Provider - FSP)
📍 Durham, North Carolina (Home-based in the U.S. or Canada)
🕒 Full-Time
📄 Job ID: R1415443
🌍 Job available in additional locations

Company Overview

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. Through Data Sciences Staffing Solutions (DSSS), IQVIA offers fully embedded resources in sponsor environments, partnering with world-class pharmaceutical and biotech companies to advance therapies.

🌐 Learn more: https://jobs.iqvia.com

Why DSSS?

Work remotely from home with flexible schedules
Collaborate with high-performance, dedicated statistical and research teams
Engage across multiple therapeutic areas, indications, and study phases
Access technical training and tailored development opportunities
Contribute to promising career trajectory and job stability through long-term engagements
Focus on advancing new therapies rather than managing budgets and change orders

Job Summary

The Senior Biostatistician provides expert statistical support across all phases of drug development programs. This includes protocol development, data analysis, regulatory submissions, and supervision of programming staff, with a strong focus on collaboration within multidisciplinary teams.

Essential Responsibilities

Validate statistical outputs and datasets
Collaborate with project teams to establish timelines
Provide statistical input and author statistical sections of clinical trial protocols
Write statistical analysis plans (SAPs)
Monitor project activities, deliverables, and resources, including CRO oversight
Collaborate on eCRF design with Data Management, Clinical Development, and Operations
Contribute to clinical study reports and regulatory documents (e.g., DSURs, Briefing Documents)
Guide and supervise programmers on dataset specifications and programming of tables, listings, and figures
Interpret and review study results for accuracy
Participate in Clinical Development Plan authorship
Support exploratory analyses and medical affairs publications
Engage in pre-IND and NDA regulatory activities
Participate in SOP and guideline development and enforcement
Consult with Research & Preclinical teams on statistical issues
Attend relevant meetings to support Biostatistics and Development Teams

Qualifications

Education & Experience

PhD in Statistics, Biostatistics, or related field with 3+ years industry experience
OR
MS in Statistics, Biostatistics, or related field with 5+ years industry experience
Minimum 1 year experience with regulatory submissions
Successful publication record
Ability to work independently with strong project management and decision-making skills

Technical Skills

Proficient in SAS and/or R for efficacy analyses and data validation
Experience with simulations and advanced statistical methodologies
Familiarity with ICH GCP guidelines and industry standards

Preferred Experience

Knowledge of neuroscience therapeutic area
Experience with CDISC standards (SDTM, ADaM, CDASH)
Experience with multiple imputations
Familiarity with multivariate analyses and biomarker analyses
Experience with statistical software including EAST

Compensation & Benefits

💰 Annual Salary Range:
$122,800 – $233,400 (based on qualifications, experience, location, and schedule)

Additional benefits may include:

Incentive plans and bonuses
Comprehensive 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 will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or other protected characteristics.

🔗 EEO Policy

How to Apply

🔗 Apply Now

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Senior Biostatistician (Functional Service Provider - Fsp)

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