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ROLE SUMMARYThe 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, US, and international markets into one team to drive efficiency through internalized work.The Platform functions to:enhance Pfizer's ability to determine unmet medical needs; support differentiated product labels for Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE); inform clinical practice on appropriate prescription and use of Pfizer's products; in collaboration with Access & Value, strengthen the value evidence package for payers and access/policy decision-makers; support measurement of short- and long-term impact of Pfizer's products to both patients and populations; support competitive differentiation.The Opportunity: This role will be responsible for intaking franchise and asset integrated evidence plans and tactics, then delivering high quality RWE, RW insights or other patient-centric evidence for prioritized projects to fully the tactic or strategic pillar, working with the RWE Strategic Planning teams.The remit spans from global and prioritized international markets, where the evidence will be used to respond to regulatory commitments / requests, HTA/government entity needs and key projects that have been prioritized in a managed work queue by the global medical strategy committee. The role is highly technical and will execute hands-on evidence generation via a combinatorial approach of cutting edge retrospective data analyses, site-based evaluations (e.g., Phase IV observational effectiveness studies, burden of illness, transmission, pathogenesis, risk factors for illness, determinants of product effectiveness and other studies), application of novel methods and technologies, and supplementation of interventional trials where appropriate with RWE through hybrid trial designs and tokenization. The Platform will insource this work to the fullest possible extent, so prospective candidates who have solely outsourced work to contract research organizations need not apply.Within the RWE Platform, a dedicated team of RWE Scientists will support the TA teams within the Hematology category, reporting to the Hematology RWE Science & Epidemiology Team Lead. Leveraging their understanding of how RWE can support the entire lifecycle from molecule to marketplace, the Hematology RWE Science & Epidemiology 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 and Patient Advocacy & External Partnerships teams. The RWE Scientist will ensure the development of consistent business rules and standards, versioning rules as care pathways evolve.ROLE RESPONSIBILITIES
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 assigned 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 Hematology RWE colleagues, & direct them to co-develop of 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 the Hematology 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.
BASIC QUALIFICATIONSCandidate 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.
6+ (with a PhD/DSc) to 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, hem/onc 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.
PREFERRED QUALIFICATIONS
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.
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 cross-functional partners across countries and different cultures.
Other Job Details:Last Date to Apply for Job: August 31, 2024Additional Location Information:This is a hybrid in-office role requiring 2-3 days on-site per weekThe annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.Market Access#LI-PFE
Vacancy caducado!