Director, Hospital RWE Scientist
The Real World Evidence (RWE) Center of Excellence (CoE) is an innovative, rapidly expanding group that provides end-to-end evidence optimization, education, communication, and maximization of data partnerships’ value within therapeutic areas (TAs) across Development, Regulatory and Commercial needs to support breakthroughs to change patients’ lives.
The Hospital Business Unit is responsible for delivering a wide range of medicines, sterile injectable devices, and sterile injectable medicines. Cross-functional pipeline and asset teams create and deliver antibiotics, antifungals, antivirals, and injectable therapies used in hospital settings such as the surgical suite and ICU.
Within the Global RWE CoE, a dedicated team of RWE Scientists will support the TA teams within the Hospital BU, reporting to the Hospital RWE Lead. Leveraging their understanding of how RWE can support the entire lifecycle from molecule to marketplace, the Hospital RWE Scientist Director will deliver timely real world insights (RWI) by understanding cross-functional pipeline / asset team’s 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. The RWE Scientist will ensure the development of consistent business rules and standards, versioning rules as care pathways evolve
The RWE Scientist Director will work closely with the Hospital RWE Lead and cross-functional teams on assets’ RWE strategy development and will direct the RWE teams’ work with pipeline / asset teams to integrate RWE into their strategic plans and the RWE teams’ external data partnership / data procurement activities (e.g., landscape assessments and due diligence or supporting contract development for external studies). They will act as a mentor / advisor to other RWE Scientists, directing their work.
Act as the deputy for the RWE Lead for consolidation of strategies and tactical plans, identification of external partners to deliver strategic RWE capabilities / data, and oversight of high quality methods and designs to inform study / project designs for Development pipeline teams, Global Product Development franchise / asset teams, BU Medical Affairs, Health Economics and Outcomes Research, Commercial and other functions’ needs
Develop tactical plans for the assigned franchise / asset team(s), co-author NIS protocols, apply high quality methods and designs to inform insights and RWE studies, generate credible RWI and high-quality, protocol-driven RWE
Provide daily direction, mentorship, motivation, and oversight of Hospital RWE resources, & direct them to co-develop of business rules, standards (e.g. for disease / cohort definitions), methods and SOPs with cross-functional colleagues
Leads teams to conduct 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
Create TA-specific RWE assessment plans and recommend emerging RWE analytical approaches, trends, and tools, and escalate high value opportunities to the Hospital RWE
Proactively identify opportunities for teams to automate Hospital analytical reports, harmonize rules with other analysis teams, and load all deliverables into the Digital RWD knowledge and insights management system.
Drive 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
Track innovative and emerging RWE analytical approaches, guidelines, and tools, and escalate high value opportunities to their RWE Lead
Document all requests and track progress toward project completion, other metrics and business goals
8+ (with an Advanced degree) to 10+ (Bachelor’s 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 Hospital development, infectious diseases, infectious disease epidemiology, host/pathogen interactions, immunology 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, Statistics/Biostatistics/Quantitative Methods, Health/Nursing /Biomedical Informatics, Public Health, health economics, or Other Biological Science fields with a substantial quantitative and computational component, or other related fields; or commensurate professional experience,
Experience assisting regulatory experts with new drug applications with FDA and EMA, specifically with 505(b)1 & 505(b)2 pathways filings
Knowledge of US 21st Century Cures Act as it pertains to the inclusion of Real World Evidence into the FDA drug approval process
Analytical consulting within life science/biopharmaceuticals industry
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
Understanding of Hospital-relevant care delivery in a hospital/clinic (ED/IP), alt-site, OP and/or home care settings highly desired
Prior experience generating RWE from anti-infectives’ specialty datasets and prospective chart reviews (anti-biotics, anti-fungal or anti-viral) highly desired
Knowledge of Hospital development, infectious disease, host/pathogen interactions, immunology, clinicogenomcs, epigenetic / NGS dataset interpretation, and other Hospital-relevant experience highly desired.
Experience with Tableau with skills developed in areas such as data ingestion, data visualization and exploratory data analysis preferred
Knowledge of efficient programming practices and the software development life cycle preferred
Demonstrated track record of participation in successful strategic collaborations or initiatives with large multi-national RWE/RWE partners preferred
In addition, Seeking candidates with the following skillsets:
Artificial Intelligence (AI) / Machine Learning (ML)/Predictive Modeling: ability and experience in creating advanced models to generate real world insights for projects
Data Visualization: passion for and experience in generating easy-to-use, interactive data visualization capabilities (e.g., Tableau) in health and life sciences that, with RWE, can be used to generate hypotheses, support rapid and informed go / no-go decisions, and illustrate patient journeys
Clinicogenomics: experience in the clinical application of next generation sequence and other biomarker tests and result reports as they pertain to clinical care or research
Project Management: experience in overseeing a program of multiple projects in a cross-matrix environment, including tracking milestones and metrics, with a history of leading or acting as a major player in real world data-related projects to coordinate colleagues and drive teams to achieve goals
Training / Education: experience in leading training and educational sessions on RWE
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.
Other Job Details
Last Day to Apply for Job: November 1st 2021
Posting Location: North America Remote
Eligible for Employee Referral Bonus
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