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 Inflammation & Immunology (I&I) TA is responsible for transforming chronic inflammatory diseases to deliver therapies that replace existing treatments that provide only symptom relief. Cross-functional pipeline and asset teams create and deliver biologics, small molecule inhibitors for multiple medical dermatologic conditions, gastroenterology conditions including ulcerative colitis and non-alcoholic steatohepatitis (NASH), and investigational therapies for rheumatologic diseases including rheumatoid arthritis and lupus.
Within the Global RWE CoE, a dedicated team of RWE Scientists reporting to the I&I RWE Lead will support the TA and other special projects. Leveraging their understanding of how RWE can support the entire lifecycle, the I&I 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 I&I RWE Scientist Manager will ensure the development and application of consistent business rules and standards, versioning rules as care pathways evolve.
The I&I RWE Scientist Manager will play a key role in delivering RWE projects and support the development of I&I RWE strategy in alignment with TA needs.
+ 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
+ Coordinate cross-functional teams to create high quality RWE from rigorously designed protocols
+ Partner with colleagues from the Strategic Partnerships and Operations team, other RWE Scientists, RWE Biostatistics, Digital RWD, and other colleagues as needed to collaboratively develop high quality methods, approaches, and protocols
+ Generate RWE through collaborations with pipeline/asset teams (eg, Early Clinical Development pipeline teams, Global Product Development franchise / asset teams, BU Medical Affairs, Health Economics and Outcomes Research, Commercial), RWE Biostatistics, and other functions
+ Proactively identify opportunities to automate I&I analytical reports, harmonize rules with other analysis teams, and create efficiencies
+ Support 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
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
+ 2+ (PhD) 3+ (with Master’s degree) to 5+ (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, 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 ability to create and deliver clear presentations to teams
+ Ability to work under pressure with a high level of autonomy and motivation and adapt rapidly within evolving digital environment
+ Well-organized with the ability to handle multiple projects and other tasks, and to prioritize knowing when to escalate issues before they become a problem
+ 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, Public Health, Health Economics and Outcomes Research, 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 in rheumatology, immunology, gastroenterology, dermatology, or other related domains highly desired
+ Prior experience generating RWE from rheumatology, dermatology or other relevant specialty datasets or chart reviews highly desired
+ Two or more years of experience in two or more of the following: Experience in clinical registries, 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; Experience in generating easy-to-use, interactive data visualization capabilities (eg, Tableau, PowerBI, Qlik, Spotfire, Looker); Knowledge of efficient programming practices and the software development life cycle; Experience integrating real world evidence across the asset lifecycle.
+ **Other Job Details:**
+ Last Date to Apply for Job: July 30, 2021
+ Additional Location Information: New York, NY; Collegeville, PA; U.S.-remote
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