The Real World Evidence (RWE) Center of Excellence (CoE) is a rapidly expanding group that provides integrated, end-to-end RWE optimization, education, communication, and maximization of data partnerships’ value within therapeutic areas (TAs) to meet both core and innovative Development, Regulatory and Commercial needs to support breakthroughs to change patients’ lives.
The Rare Disease TA is responsible for creating and commercializing therapies for rare disorders. Cross-functional pipeline and asset teams create and deliver biologic medicines, small molecules and exploratory gene therapies.
Within the Global RWE CoE, a dedicated team of RWE Scientists reporting to the Rare Disease RWE Lead will support the TA. Leveraging their understanding of how RWE can support the entire lifecycle, the Rare Disease RWE Scientist Manager will deliver timely real world insights (RWI) and RWE in collaboration with cross-functional teams, provide guidance on appropriate sources of real world data and methods, and will create easy-to-understand summary reports. Where external data sources or services are required, they will help oversee / consult for any external RWE studies. For both approaches, the RWE Scientist Manager will ensure the development and application of consistent business rules and standards, versioning rules as care pathways evolve.
The Rare Disease RWE Scientist Manager will play a key role in delivering RWE projects and support the development of RD RWE strategy to keep up with the evolving regulatory and payer environment.
Create real-world insights for feasibility assessments, go/no-go decisions, co-design and create dashboards to inform cross-functional teams’ hypothesis generation, generate timely and detailed insights
Coordinates cross-functional teams to create high quality RWE from rigorously designed protocols
Partner with and coordinate the Rare Disease and Strategic Partnerships and Operations RWE Leads, other RWE Scientists, RWE Biostatistics, Digital RWD and other colleagues as needed to collaboratively develop high quality methods, approaches, protocols and designs
Generate RWE through collaborations with the pipeline / asset teams (eg, Early Clinical Development pipeline teams, Global Product Development franchise / asset teams, BU Medical affairs, HEOR, Commercial), RWE Biostatistics and other functions
Proactively identify opportunities to automate and create efficiencies, harmonize rules with other analysis teams
Lead vendor due diligence for potential partnerships or new sources of data / technology as directed
Document all requests and track progress toward project completion, other metrics and business goals
2+ (with a master’s degree) to 3+ (Bachelor’s degree) years’ experience in the pharmaceutical industry/consulting
Proven successful track record of scientific analysis of real- world data for scientific, business, quality or other purposes
Knowledge of Electronic Health Records, medical and pharmacy claims, patient registries, patient participating research networks and other real-world data sources
Ability to critically evaluate analytic results against the literature, subject matter expert feedback or other reliable sources to ensure biological and medical credibility in alignment with cross-functional team strategy / priorities
Two or more years of experience in communicating in verbal and written form with all levels of personnel with diverse backgrounds, and able to create and deliver clear presentations to teams
Ability to work under pressure with a high level of autonomy and internal motivation and adapting rapidly within evolving digital environment
Experience with protocol development and execution for non-interventional studies using a variety of analytical techniques applied to various databases
Two or more years of hands-on experience of query and analytic languages and technologies (eg, SQL, R, SAS, IHD, Aetion) and of relevant biological and medical data standards (eg, HGNC / Entrez, ICD, CPT)
Ability to rapidly learn new domains to understand the latest scientific or medical findings and incorporate them into projects as appropriate; to interpret data dictionaries and other technical documentation
The ideal candidate will have a Master’s degree with 3+ years/PhD with 1+ years in RWE analytics, Economics, Bioinformatics, Epidemiology, Biostatistics, Other Biological Science fields with a substantial quantitative and computational component, other related fields or commensurate professional experience
2+ years of experience working in real world data analytics in healthcare, clinical research, life science or other related organizations
Experience with Hemophilia, Duchenne’s Muscular Dystrophy, growth hormone deficiency, rare cardiac conditions, or other Rare Disease priority areas highly desired
Two or more years of experience in two or more of the following:
Experience in clinical registry, patient generated health data, unstructured clinical data and other health data sources
Understanding global regulatory guidance for appropriate use and submission of RWE
Artificial Intelligence (AI) / Machine Learning (ML): ability and experience in creating advanced models to generate real world insights
Data Visualization: passion for and experience in generating easy-to-use, interactive data visualization capabilities (e.g., Tableau, PowerBI, Qlik, Spotfire, Looker)
Knowledge of efficient programming practices and the software development life cycle
Clinicogenomics: understand the clinical application of genomic, transcriptomic and other biomarker tests and result reports as they pertain to clinical care or research
Experience integrating real world evidence in early clinical development.
Other Job Details:
Additional Location Information: New York, NY; Collegeville, PA; US - Remote