ROLE SUMMARY

The Platform: The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from proof of concept (POC) trials through LOE for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products. The Platform fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international markets into one team to drive efficiency through internalized work.

Within the RWE Platform, a dedicated team of RWE Scientists will support the TA teams within the Rare Disease category, reporting to the Rare Disease RWE Scientific Team Lead. Leveraging their understanding of how RWE can support the entire lifecycle from molecule to marketplace, the Hematology RWE Director will deliver timely real-world insights (RWI) by understanding cross-functional pipeline / asset team's strategic objectives and timelines, collaborate with the team and RWE Biostatistics & other relevant colleagues to generate RWE, and direct creation of easy-to-understand summary reports. They act as an RWE expert, advising on what type of real-world data and which sources are most appropriate for completing objectives, partnering closely with the Platforms & Partnerships team. The RWE Scientist will ensure the development of consistent business rules and standards, versioning rules as care pathways evolve.

• Execute on prioritized tactical plans with actionable projects, identify external partners to deliver strategic RWE capabilities / data, and oversight of high-quality methods and designs to inform study / project designs for R&D franchise / asset teams, CMAO, Health Economics and Outcomes Research, Commercial and other functions' needs
• Develop project plans and protocols for the Hematology franchise / asset team(s), apply high quality methods and designs to inform insights and RWE studies, generate credible RWI, and high-quality, protocol-driven RWE studies
• Provide daily mentorship, motivation, and guidance to more junior Rare Disease RWE colleagues, & direct them to co-develop business rules, standards (e.g. for disease / cohort definitions), methods and SOPs with cross-functional colleagues
• Conducts feasibility assessments to determine appropriate internal / external real-world data sources and directs creation of RWI for internal insights informing go/no-go decisions, hypothesis generation, and decision-making for executives, teams and business development
• Coordinates cross-functional teams, RWE Biostatistics and other colleagues to create high quality RWE from rigorously designed protocols
• Creates TA-specific RWE assessment plans and recommend emerging RWE analytical approaches, trends, and tools, and escalate high value opportunities to Rare Disease colleagues
• Proactively identifies opportunities for teams to automate analytical reports, harmonize rules with other analysis teams, and load all deliverables into the knowledge and insights management system.
• Supports landscape assessments, new data / tool / partner due diligence assessments based on understanding evolving healthcare, technology and other industries with Customers, RWE Partnerships Managers, Digital RWD Enterprise Enabling Platform, RWE Biostatistics and other relevant partners
• Tracks innovative and emerging RWE analytical approaches, guidelines, and tools, and escalate high value opportunities to their RWE Lead, and solicit innovation and efficiency approaches from the RWE Innovation Lead
• Documents all requests and track progress toward project completion, other metrics and business goals.

• Demonstrated successful history of high levels of collaboration across matrixed team
• 6+ (with a PhD/PharmD), 8+ (Masters degree) years' experience with a proven successful track record of scientific analysis for observational/non-interventional studies, healthcare analytics, RWE generation, other research studies or clinical quality improvement studies, with specific experience with a range of real world data such as hospital chargemaster data, EHR, medical or pharmacy claims, patient registries, PROs or other 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
• Strong experience in communicating in verbal and written form with all levels of personnel with diverse backgrounds
• Ability to work under pressure with a high level of autonomy and motivation
• Scientific expertise in development, medical affairs or related domains, or the interest and ability to rapidly learn these domains to understand and proactively apply the latest scientific findings for projects
• Quality focused and well organized
• Ability to handle mentorship and oversight of team members, leading them to adapt in a changing digital environment, and to prioritize / execute multiple projects and other tasks, knowing when to escalate issues before they become major problems
• Knowledge of query and analytic languages and technologies (e.g., SQL, R, SAS, IHD, Aetion) and of relevant biological and medical data standards (e.g., HGNC / Entrez, ICD, CPT)
• Ability to create and interpret data dictionaries, functional and non-functional requirements for data visualization or other tools, and other technical documentation.

• Master's degree or higher in Epidemiology or Biostatistics with a substantial quantitative and computational components or commensurate professional experience,
• Experience assisting regulatory experts with new drug applications with FDA and EMA
• Knowledge of US 21st Century Cures Act as it pertains to the inclusion of Real World Evidence into the FDA drug approval process
• Significant years of focused experience in any of the following areas: real world data analytics, observational or NIS research design, clinical or translational research, pharmaceutical Research & Development, or similar environment highly desired
• Understands relevant standard of care & real world healthcare delivery in a hospital/clinic (ED/IP), alt-site, OP and/or home care settings highly desired.
• Knowledge of efficient programming practices and the software development life cycle preferred
• Demonstrated track record of participation in successful cross-functional partners across countries and different cultures.