IQVIA · 4 days ago
FSP Principal Biostatistician- Early Phase Clinical Development(PK)
United States
Full-time
Remote
Senior Level, Lead/Staff
$116K/yr - $244K/yr
3+ 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 drug development programs in early phases of development, focusing on healthy normal studies with PK and PD endpoints.
AnalyticsHealth CareLife Science
Responsibilities
Collaborate with multidisciplinary project teams to establish project timelines
Provide statistical input to study synopses and protocols
Write the statistical sections of clinical trial protocols, including sample size calculations, while consulting with internal and external experts
Review eCRF and other data management documents
Create or review randomizations and related specifications
Write or review statistical analysis plans, dataset and TLF specifications
Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures
Provide statistical review and validation of the same
Use SAS and/or R to perform inferential analyses and validate key data derivations
Interpret study results and review reports of study results for accuracy
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources
Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK with statistical expertise
Contribute to clinical study reports and other regulatory documents e.g., DSURs, IB, etc
Support exploratory analyses
May support IND activities
Qualification
Required
PhD in Statistics, Biostatistics, or related field with 3+ years industry experience
MS in Statistics, Biostatistics, or related field with 5+ years of industry experience
2+ years of experience in statistical analysis of non-compartmental PK endpoints in pharmaceutical industry
Understanding of ICH GCP, regulatory guidance for clinical pharmacology studies and industry practices/standards
Experience with CDISC, including SDTM, ADaM, CDASH
Demonstrated ability to work independently in project management and decision making
Able to effectively communicate his/her ideas and to manage programmers in a constructive manner
Proficiency in SAS to perform analyses and validate important data derivations
Preferred
Knowledge of basic statistical modeling, simulations and PD/biomarker analyses
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 on project budgets and change orders
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
Company data provided by crunchbase