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Job Summary Otsuka is looking for a strong Statistician in the Medical and Real World Data Analytics organization to provide statistical expertise for analysis of data from observational studies, claims, registries, market research, sensors, publicly available sources, and other real world data sets across the globe. The overall purpose is to support evidence generation towards design of new trials, assessing effectiveness of treatments and their economic value, payer negotiations, supporting health technology assessments, and other regulatory interactions through statistical analyses on various forms of Real World data. The role will manage the timely execution of statistical and research methodological components to meet project objectives and has a deep understanding of statistical methodologies and requirements for statistical standards.Job Description Work closely with statisticians, data scientists and data programmers, and stakeholders including Medical Affairs, Value and Real World Evidence, and Market Access to provide end-to-end statistical expertise and delivery of analyses, results, and reports in a readily consumable way Utilize statistical knowledge of and expertise to provide end-to-end statistical support for Real World studies, observational studies, and data from registries, surveys, healthcare utilization databases, and evolving public data sources Design and specify the structure of the datasets that will be delivered for statistical analysis to ensure that the structure follows any existing company standard and is appropriate for analyses Identify data and analytics gaps and to recommend new avenues for collecting data along with statistical methodologies to analyze it for intended outcomes Actively participate in project/study team meetings. Develop statistical sections of protocols; participate in mock-ups, review, and approve tables, listings and graphs specifications. Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and other external data. Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions. Work closely with clinicians, programmers, other statisticians and data scientists, and publication managers to generate QC outputs for publications, review publications to ensure accuracy, quality and soundness of statistical methodologies; coordinate, oversee and ensure quality delivery from vendors and their resources Design statistical analysis, write analysis plans, conduct statistical analysis, interpretation of analyses results, and write and review reports. Ensure quality and timelines are met. Design and author study Analysis Plans, including table, figure, and listing shells. Develop cross-functional data review plan, key reports, and data dissemination plan in order to facilitate the review, summary, and dissemination of key study data/results. Produce or ensure availability of analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and complying with pre-defined project / study standards. Participate in study concept, protocol and SAP development for Real World studies and data analyses and ensure appropriateness of study design, sample size calculations and statistical methodologies proposed Ensure delivery of quality and on-time results by vendors and their resources, when applicable Contributes to external interactions with regulators, payers, review boards, etc.Qualifications Required A PhD or Masters in statistics, biostatistics, econometrics, mathematics, or a related technical field. 5+ year of experience Healthcare, Pharma or related Industry Deep understanding and broad exposure to Real World Data sets along with their appropriateness for evidence Strong statistical background demonstrated by publications and/or other achievements Expertise in SAS and other statistical programming languages, such as R, Splus, python Hands on technical and project leadership with accountability Expert understanding based on substantial understanding of classical and modern analyses methodologies Understanding of claims data sets (e.g. MarketScan), medical records databases, EMR/HER data, Strategic and outcomes-oriented mindset that balances depth, breadth to demonstrate the right value Strong technical writing, editing, and communication skills along with collaborative mindset Excellent organizational skills with an ability to embrace change and effectively manage multiple projects Ability to present and defend statistical analyses at Industry forums and regulatory agencies Experience with multiple therapeutic areas (e.g. CNS, renal, digital solutions) Finally, a desire backed by will and commitment to make a positive difference to human healthPreferred Experience with design and analyses of observational studies, Health Economic data and research is strongly preferred Prior work experience in epidemiology, health economic and outcome research, drug development or clinical research Experience with Data Science, Machine Learning, and Artificial Intelligence Experience with mathematical modeling and simulation Experience with latest technologiesDisclaimer This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected statusDisclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud Scams Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
