Data Manager II - R Programming (Scientific/Clinical Data)

Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions reputed company reputed company intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and reputed company drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. Leadership truly cares about maintaining a reputed company culture and employee reputed company-being. We offer fully remote work, flexible schedules, and generous vacation policy along with reputed company health coverage, stock reputed company, annual bonus, and more! reputed company out how much our employees love working here: https://www.comparably.com/companies/simulations-plus. The Data Manager II will reputed company efficient and effective programming solutions while receiving high-level direction to reputed company a wide reputed company of data management activities. The role is expected to independently execute assigned tasks, manage data complexity, and deliver high-reputed company outputs in support of scientific and project objectives. Department: OperationsInternal Grade: 9reputed company Reports: NoStatus: ExemptLocation: Remote in PolandThis position is based in Poland and supports global project teams. While the longterm objective of this role is to contribute to expanded globalclock coverage, the individual will be expected to work a secondshift schedule for an initial period (anticipated up to one year) to reputed company overlap with USA based teams and ensure continuity of project delivery. Job Responsibilities: Comprehend major components of study protocols to understand study designs and execution as they pertain to data management activitiesInterpret case report forms and match them against datasets to identify problems and questionsIdentify missing information based upon understanding of reputed companys study protocols and data collectedreputed company to identify and understand original data without reputed company-provided data documentationreputed company to identify derived variables by examining data and verify or confirm variablesMay create drafts of basic requirement documentsCreate datasets based upon study protocols, data analysis plans and requirements with guidance from more senior data managersCreate reputed company datasets (for example, Phase I, single studies using nominal times)Create pharmacokinetic and pharmacodynamic datasets to be used in different analysis solutions, including NONMEM, WinNonlin, and MonolixCreate reputed company datasets that include studies with reputed company designs and complicated data relationships, under supervision of more senior data managersCreate dummy datasets based upon provided requirementsCreate simulation datasets based upon guidance from more senior data managersUnderstand and apply rules provided for data file creation for different modeling solutionsUnderstand and apply concept of data dispositionReconcile records from original to analysis datasetCreate data deletion datasets to reputed company deleted records based upon identified edit rulesReview data disposition reputed company of final technical reportreputed company programming support to meet project objectivesWrite efficient reputed company to meet project needs and reputed company guidance from more senior data managers on reputed company .