BioBridges
Overview
We are seeking an experienced Real-World Evidence (RWE) Expert with deep expertise in CDISC data standards to support the design, execution, and regulatory submission of high-quality RWE studies. This role bridges scientific evidence generation and regulatory-grade data management to ensure RWE is structured, traceable, and compliant with global health authority expectations.
The ideal candidate brings strong experience in RWE study design, data standardization, and regulatory interactions, with the ability to transform real-world data (RWD) into submission-ready formats that integrate with clinical trial datasets. Key Responsibilities
RWE Strategy & Regulatory Alignment 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. CDISC Data Standards & Data Management
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). Analytical, Technical & RWE Expertise
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). Leadership & Collaboration
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. Requirements
Qualifications
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.
BioBridges provides equal employment opportunities to all employees and applicants for employment, and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We are seeking an experienced Real-World Evidence (RWE) Expert with deep expertise in CDISC data standards to support the design, execution, and regulatory submission of high-quality RWE studies. This role bridges scientific evidence generation and regulatory-grade data management to ensure RWE is structured, traceable, and compliant with global health authority expectations.
The ideal candidate brings strong experience in RWE study design, data standardization, and regulatory interactions, with the ability to transform real-world data (RWD) into submission-ready formats that integrate with clinical trial datasets. Key Responsibilities
RWE Strategy & Regulatory Alignment 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. CDISC Data Standards & Data Management
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). Analytical, Technical & RWE Expertise
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). Leadership & Collaboration
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. Requirements
Qualifications
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.
BioBridges provides equal employment opportunities to all employees and applicants for employment, and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.