Real-World Evidence (RWE) Expert jobs in United States
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BioBridges · 16 hours ago

Real-World Evidence (RWE) Expert

positionUnited States
timeFull-time
remoteRemote
senioritySenior Level, Lead/Staff
date15+ years exp

BioBridges is seeking an experienced Real-World Evidence (RWE) Expert with a deep expertise in CDISC data standards to support the design, execution, and regulatory submission of high-quality RWE studies. The role involves bridging scientific evidence generation and regulatory-grade data management to ensure RWE is structured, traceable, and compliant with global health authority expectations.

Life ScienceMedical DevicePharmaceutical
Hiring Manager
Karen Fanto, PHR
linkedin

Responsibilities

Design and execute regulatory-grade RWE studies to support product approvals, label expansions, and post-marketing commitments
Apply observational and causal inference methodologies, including external control arms and hybrid study designs
Engage with global health authorities (FDA, EMA, MHRA, PMDA) on RWE evidentiary strategy, data traceability, and acceptability
Develop RWE evidence-generation strategies across the product lifecycle
Serve as the subject-matter expert on CDISC standards (SDTM, ADaM, Define.xml; SEND a plus)
Lead mapping and transformation of RWD (EHR, claims, registries, PROs) into CDISC-compliant datasets
Ensure end-to-end data lineage, traceability, validation, and conformance
Partner with data management, programming, and biostatistics teams; oversee vendors/CROs
Utilize industry tools (e.g., Pinnacle 21, SAS Define, OpenCDISC)
Conduct advanced data wrangling, validation, and analysis using R, SAS, or Python
Support OMOP-to-CDISC conversions and metadata-driven automation
Design and execute complex RWE, HEOR, observational, and chart-review studies, including surveys and questionnaires
Ensure compliance with applicable data-privacy regulations (HIPAA, GDPR)
Act as a cross-functional bridge between RWE science, data standards, and regulatory affairs
Lead RWE data strategy initiatives, mentor junior team members, and manage client communications
Present methodologies and results with an emphasis on transparency and reproducibility

Qualification

CDISC data standardsRWE study designRegulatory submissionsData standardizationData managementData privacy regulationsPublicationsLeadershipCollaborationCommunicationMentoring

Required

Advanced degree (PhD, PharmD, MD, or equivalent) in epidemiology, biostatistics, data science, public health, or related field
15+ years of experience in RWE generation, regulatory submissions, or CDISC implementation within pharma, biotech, or consulting
Proven experience delivering regulatory-grade RWE supporting approvals, label expansions, or post-marketing commitments

Preferred

Experience with OMOP-CDISC interoperability
Participation in CDISC, PHUSE, or ISPOR working groups
Familiarity with AI/ML-enabled RWE analytics
Publications or presentations in RWE or data-standards methodology

Company

BioBridges

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BioBridges delivers the expertise, services and technologies to bridge life sciences companies from discovery through commercialization.
dateFounded in 2005
location
Morrisville, North Carolina, USA
people-size201-500 employees
web-link
http://biobridges.com/

Funding

Current Stage
Growth Stage
Total Funding
unknown
2017-09-14Acquired

Leadership Team

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Jennifer Boscia
Chief Financial Officer
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Company data provided by crunchbase