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Company

IQVIA · 10 hours ago

Principal Biostatistician FSP, RWE

Durham, NC

Full-time

Remote

Senior Level, Lead/Staff

$131K/yr - $244K/yr

7+ years exp

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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 research design, methodologies, data sources, analytic techniques, and reporting.

Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.

Provides strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians.

Leverages administrative claims, electronic medical records, or other real-world data and recommends optimal study designs.

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.

Ensures quality and consistency of analytics deliverables.

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 RWE.

Collaborates with and manages vendors to ensure project timelines and goals are met.

Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

StatisticsBiostatisticsRWE applicationsStatistical software SASStatistical software RObservational researchRegulatory submissionsStatistical analysis plansElectronic medical recordsHigh-level competencyICH GCP knowledge

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.

Experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements.

Knowledge of global regulatory and HTA requirements for RWE

Demonstrated ability in evaluation and development of RWE from conceptualization through application.

Experience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development.

Extensive working experience with stakeholders such as medical affairs and health economics

Hands-on experience with prospective and retrospective observational studies

Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.

Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion.

High level of competency using standard statistical software such as SAS or R

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

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

Glassdoor

3.9

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

Founded in 1982

Danbury, Connecticut, USA

10,001+ employees

https://www.iqvia.com

H1B Sponsorship

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