IQVIA · 10 hours ago
Principal Biostatistician FSP, RWE
United States
Full-time
Remote
Senior Level, Lead/Staff
$131K/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 a full range of statistical support for drug development based on real world evidence (RWE).
AnalyticsHealth CareLife Science
Responsibilities
Collaborate with multi-disciplinary project teams to establish project goals and timelines
Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies
Serves as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting
Writes statistical analysis plans
Provides strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians
Leverages administrative claims, electronic medical records, registries, or other real-world data and recommends optimal analysis
Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives
Develops high quality study protocols, statistical analysis plans, study reports, and other study documents
Identifies innovation opportunities for the use of RWD
Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD
Commitment to maintaining the highest standards of data accuracy and integrity by implementing rigorous quality control processes throughout the data handling and analysis phases
Demonstrated ability to quickly adapt to new requirements and efficiently handle ad-hoc requests
Qualification
Required
Collaborate with multi-disciplinary project teams to establish project goals and timelines
Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies
Serves as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting
Writes statistical analysis plans
Provides strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians
Leverages administrative claims, electronic medical records, registries, or other real-world data and recommends optimal analysis
Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives
Develops high quality study protocols, statistical analysis plans, study reports, and other study documents
Identifies innovation opportunities for the use of RWD
Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD
Commitment to maintaining the highest standards of data accuracy and integrity by implementing rigorous quality control processes throughout the data handling and analysis phases
Demonstrated ability to quickly adapt to new requirements and efficiently handle ad-hoc requests
In-depth knowledge of RWE databases, including large administrative claims data, EMR, disease registries, and clinical trial data
Demonstrated ability in evaluation and development of RWE from conceptualization through application
Familiarity with LOINC codes, reimbursement and lab data interpretation, and ability to implement surrogate variable algorithms (e.g., phenotype definitions, proxies for clinical endpoints)
Ability to execute statistical analysis plans using advanced programming techniques to perform detailed and complex analyses relevant to real-world evidence
Ability to effectively interpret and communicate research results to internal and external audiences
Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standard
Knowledge of global regulatory and HTA requirements for RWE
Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion
SME-level proficiency in SAS programming tailored to handle complex inclusion and exclusion criteria, conduct propensity score matching, and develop outcome metrics
Ph.D. in Statistics, Biostatistics, or related field with 5+ years of industry experience
M.S. in Statistics, Biostatistics, or related field with 7+ years of industry experience
Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries
Solid hands-on experience as Project statistician with real-world data, including EMR/EHR and claims datasets (e.g., Humedica, Optum, MarketScan, CMS, Komodo, Truveta, TrinetX, etc.)
Fluency in LOA, mock TFLs, protocol and SAP
Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD
Experience with CDISC ADAM datasets
Extensive working experience with stakeholders such as medical affairs and health economics
Preferred
Understanding of payer landscape, health economic outcomes, and value demonstration frameworks
Exposure to regulatory submissions, HTA support
Expertise in R is also valued
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
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