IQVIA · 1 day ago
Principal Biostatistician FSP, Late Phase
United States
Full-time
Remote
Senior Level, Lead/Staff
$116K/yr - $244K/yr
5+ years expIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients, collaborating with various teams to ensure project objectives are met and contributing to regulatory documents.
AnalyticsHealth CareLife Science
Responsibilities
Collaborate with multi-disciplinary project teams to establish project objectives and timelines
Write the statistical sections of clinical trial protocols, while consulting with internal and external experts
Author statistical analysis plans
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources
Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise
Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc
Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures
Interpret study results and review reports of study results for accuracy
Support exploratory analyses
Participate in pre-IND or NDA activities
Participates in other activities and meetings to support Biostatistics and the Development Team as needed
Qualification
Required
PhD in Statistics, Biostatistics, or related field with 5+ years industry experience
MS in Statistics, Biostatistics, or related field with 7+ years of industry experience
At least 3 years in Phase 2/3 clinical trial experience
Demonstrated ability to work pro-actively and independently
Able to effectively communicate his/her ideas and to manage programmers in a constructive manner
Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary
Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards
Experience with CDISC, including SDTM, ADAM, CDASH
Preferred
Interaction with regulators including Advisory Committee meetings
2+ years of experience with renal therapeutic area
Benefits
Home-based remote working opportunities.
Work/life balance as well as flexible schedules.
Collaborating with motivated, high-performance, statistical and research teams.
Technical training and tailored development curriculum.
Research opportunities that match your unique skillset.
Promising career trajectory.
Job stability: long-term engagements and re-deployment opportunities.
Focus on bringing new therapies to market rather than project budgets and change orders.
Experience with regulatory submissions.
Engaging, fast-paced environment.
Good work-life balance.
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
Sabin Vaccine Institute
2025-12-04
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