Senior Biostatistician (FSP)
Location: Home-based (U.S. or Canada)
Job Type: Full-time
Job ID: R1415443
Department: Data Sciences Staffing Solutions (DSSS / DS3)
Available Locations: North Carolina | Remote
About the Role
IQVIA’s Data Sciences Staffing Solutions (DSSS) — also known as DS3 — provides sponsor-embedded professionals through a Functional Service Provider (FSP) model.
As a Senior Biostatistician, you’ll deliver high-level statistical expertise across all phases of drug development, working directly within sponsor environments while enjoying the flexibility and career growth opportunities of a global CRO.
Why Join DSSS / IQVIA?
💻 100% Remote, home-based flexibility (U.S. or Canada)
⚖️ Work-life balance with flexible schedules
🧠 Exposure to multiple therapeutic areas and study phases
👥 Collaborate with high-performance research and statistical teams
📚 Continuous technical training and tailored development programs
🚀 Promising career growth with long-term engagement and redeployment options
🎯 Focus on advancing therapies, not managing budgets or change orders
Key Responsibilities
Validate statistical outputs and datasets to ensure accuracy and compliance.
Partner with cross-functional project teams to set timelines and deliverables.
Provide statistical input and write statistical sections of clinical trial protocols.
Develop and maintain Statistical Analysis Plans (SAPs).
Oversee internal and CRO project activities related to data analysis and reporting.
Collaborate with Data Management, Clinical Development, and Clinical Operations on eCRF design and data standards.
Contribute to Clinical Study Reports (CSRs) and regulatory documents (e.g., DSURs, Briefing Documents).
Supervise and guide programmers in developing ADaM datasets, tables, listings, and figures.
Interpret and review study results for accuracy and statistical validity.
Participate in the creation of Clinical Development Plans, exploratory analyses, and publications.
Contribute to pre-IND and NDA regulatory activities.
Support development and enforcement of SOPs and statistical guidelines.
Provide consultation to Research and Preclinical teams on statistical methodologies.
Qualifications
Education
PhD in Statistics, Biostatistics, or related field with ≥3 years of industry experience
OR
MS in Statistics, Biostatistics, or related field with ≥5 years of industry experience
Experience & Skills
Minimum 1 year experience with regulatory submissions (e.g., NDA, BLA)
Proven record of peer-reviewed publications
Strong independent project management and decision-making skills
Proficient in SAS and/or R for data analysis and validation
Familiarity with simulation techniques for study design or data modeling
Effective communicator and capable of managing programmers constructively
Desired Experience
Knowledge of ICH GCP and general industry standards
Proficiency with R, EAST, or similar statistical software
Experience in Neuroscience therapeutic area
Expertise in CDISC standards (SDTM, ADaM, CDASH)
Experience with multiple imputations, multivariate analyses, and biomarker analytics
Compensation
💰 Base Salary Range: $122,800 – $233,400 (annualized)
💎 Additional Compensation & Benefits:
Performance-based incentives or bonuses
Comprehensive health and welfare benefits package
Professional training and development opportunities
About IQVIA
IQVIA is a global leader in clinical research and healthcare analytics, enabling the development and commercialization of innovative medical treatments to improve global health outcomes.
🔗 Learn more: https://jobs.iqvia.com
Equal Opportunity Statement
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
🔗 Equal Opportunity Policy
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