Principal Biostatistician (FSP), Early Phase – Remote (U.S. or Canada)
Location: Durham, North Carolina (Home-Based)
Employment Type: Full-Time
Requisition ID: R1415305
Additional Locations Available
Position Overview
IQVIA’s Data Sciences Staffing Solutions (DSSS/DS3) division is seeking a highly skilled Principal Biostatistician to support early-phase clinical development programs through a Functional Service Provider (FSP) model. This role provides the opportunity to work fully embedded within leading global pharmaceutical and biotechnology sponsors while leveraging industry-leading CRO expertise.
This position focuses on delivering high-quality statistical support for early-phase oncology and dose-escalation studies, contributing directly to the development of innovative therapies.
Key Responsibilities
Collaborate with cross-functional project teams to establish timelines and statistical deliverables.
Provide statistical expertise for clinical study protocols and author statistical sections.
Develop comprehensive Statistical Analysis Plans (SAPs).
Monitor timelines, resource needs, and deliverables across internal teams and CRO partners.
Partner with Data Management, Clinical Operations, and Clinical Development to ensure statistical alignment.
Contribute to clinical study reports, DSURs, briefing documents and other regulatory submissions.
Guide statistical programmers on dataset specifications and programming/validation of TLF outputs.
Interpret study data, validate results, and ensure accuracy of statistical conclusions.
Support Clinical Development Plan development and medical affairs publications.
Participate in pre-IND and NDA preparations.
Provide statistical leadership in early-phase oncology, dose escalation, and efficacy endpoint planning.
Engage in department-level activities to support Biostatistics and development teams.
Required Qualifications & Experience
PhD in Statistics, Biostatistics, or related field with at least 5 years of industry experience,
OR
MS degree with a minimum of 7 years of relevant biostatistics experience.
Prior experience in early-phase clinical trials, with preference for early-phase oncology.
Experience supporting dose escalation studies, early efficacy endpoints, and solid-tumor trials.
Minimum 1 year of regulatory submission experience.
Proven track record of scientific publication.
Demonstrated ability to work independently, manage timelines, and drive statistical decision-making.
Strong communication skills with the ability to guide and mentor statistical programmers.
Proficiency in SAS and/or R for analysis, validation, and data derivations.
Solid understanding of ICH GCP, early-phase trial methodology, and industry standards.
Experience with CDISC standards including SDTM, ADaM, and CDASH.
Preferred Skills
Familiarity with R, statistical simulation tools, and early-phase modeling techniques.
Experience with Bayesian statistical methods.
Knowledge of simulations, multivariate methods, biomarker analyses, and tools such as EAST.
Why Join IQVIA DSSS?
100% remote work-from-home flexibility (U.S. or Canada).
Balanced workload and flexible scheduling for strong work-life integration.
Long-term, stable engagements with opportunities for re-deployment.
Access to advanced training, technical development programs, and research opportunities tailored to your expertise.
Collaborative environment with high-performance statistical and clinical research teams.
Direct involvement in accelerating early-phase drug development and advancing breakthrough therapies.
Compensation & Benefits
Annual base salary range: $122,800.00 – $233,400.00, depending on experience, skills, education, and location.
Eligibility for incentive programs, bonuses, health and welfare benefits, and additional employee resources.
About IQVIA
IQVIA is a global leader in clinical research, advanced analytics, and healthcare intelligence. With a focus on shaping the future of medical innovation, IQVIA enables biopharma organizations to accelerate clinical development and improve patient outcomes worldwide.
IQVIA is an equal opportunity employer and complies with all applicable employment laws.
Apply Now
Take the next step in advancing early-phase clinical research and shaping tomorrow’s therapies.
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