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Amgen is seeking a dedicated Associate Biostatistical Programmer to join our Center for Observational Research (CfOR) organization, based in Hyderabad, India. This crucial role involves generating Real-World Evidence (RWE) to support Amgen products throughout the drug development lifecycle. The successful applicant will collaborate with teams across multiple time zones to fulfill requests, clarify requirements, escalate issues, and deliver high-quality results. The Associate Biostatistical Programmer will report to a locally based Biostatistical Programming Manager. The Associate Biostatistical Programmer will be responsible for hands-on programming and results delivery. Additionally, they will be responsible for manipulating large databases and generating reports to enable epidemiologists to explore and generate RWE from real-world healthcare data assets.
Job Responsibility:
Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications
Provide technical solutions to programming problems within CfOR
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Manage all programming activities, according to agreed resource and timeline plans
Ensure all programming activities on the project adhere to departmental standards
Write and/or review and approve all programming plans
Write and/or review and approve analysis dataset specifications
Write, test, validate and execute department-, product- and protocol-level macros and utilities
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
Actively participate in external professional organizations, conferences and/or meetings
Provide input to and participate in intra-departmental and CfOR meetings
Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
Requirements:
Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least two (2) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Experience in statistical programming using SAS and SQL
Nice to have:
Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
Experience with R and Python
Experience with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)