Principal Biostatistician (FSP), Late Phase – Remote (U.S. or Canada)
Location: Durham, North Carolina (Home-Based)
Job Type: Full-Time
Requisition ID: R1460510
Additional Locations Available
About the Role
IQVIA’s Data Sciences Staffing Solutions (DSSS) division is seeking an experienced Principal Biostatistician to support late-phase clinical programs through a Functional Service Provider (FSP) model. This role offers the opportunity to work fully embedded within leading pharmaceutical and biotechnology sponsors, contributing directly to innovative late-phase research and regulatory submission activities.
The ideal candidate brings extensive biostatistics expertise, advanced analytical capabilities, and proven experience supporting Phase II/III clinical trials in a global environment.
Key Responsibilities
Collaborate with cross-functional study teams to define project goals, statistical deliverables, and timelines.
Develop statistical sections of clinical trial protocols in consultation with internal and external experts.
Author and maintain Statistical Analysis Plans (SAPs).
Oversee project timelines, deliverables, and CRO activities to ensure high-quality outputs.
Provide statistical leadership across Data Management, Clinical Development, and Clinical Operations.
Contribute to clinical study reports and regulatory submissions, including NDA, DSUR, ISS, and ISE.
Guide statistical programmers on dataset specifications and validation of TLF outputs.
Interpret study results and ensure accuracy of statistical reporting.
Support exploratory analyses and participate in pre-IND or NDA preparations.
Attend internal meetings and contribute to process improvement within Biostatistics.
Required Experience & Qualifications
PhD in Statistics, Biostatistics, or related discipline with at least 5 years of industry experience,
OR
MS degree with a minimum of 7 years of biostatistics experience in the pharmaceutical or CRO sector.
Minimum 3 years of experience in Phase II/III clinical trials.
Strong proficiency in SAS or R for statistical analyses and validation.
Expertise in CDISC standards, including SDTM, ADaM, and CDASH.
Solid understanding of ICH GCP, ICH E9, and global regulatory expectations.
Demonstrated ability to work independently with proactive decision-making and clear communication skills.
Ability to effectively supervise programmers and collaborate across functional teams.
Preferred Qualifications
Experience interacting with regulatory agencies, including Advisory Committee meetings.
At least 2 years of experience in renal/related therapeutic areas.
Prior involvement in late-phase or real-world evidence environments.
Why Join IQVIA DSSS?
Fully remote work-from-home flexibility (U.S. or Canada).
Balanced workload with flexible scheduling.
Long-term project stability supported by global FSP partnerships.
Opportunities for technical training, professional development, and career advancement.
Engagement with top-tier pharmaceutical and biotechnology sponsors.
Strong focus on innovation and accelerating therapy development.
Compensation & Benefits
Annual base pay range: $115,900.00 – $243,900.00, dependent on experience, location, and job-related qualifications.
Eligibility for incentive plans, bonuses, health and welfare benefits, and additional employee programs.
About IQVIA
IQVIA is a global leader in clinical research, advanced analytics, and healthcare technology. With innovative data-driven solutions, IQVIA supports life sciences organizations in accelerating clinical development and improving global health outcomes.
IQVIA is an equal opportunity employer and does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, national origin, disability, veteran status, or any legally protected status.
Apply Now
Advance your career while contributing to late-phase clinical development that impacts global healthcare.
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