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Amgen is seeking a dedicated Senior Statistical 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 Senior Statistical Programmer will report to a locally based Biostatistical Programming Manager. The Senior Statistical Programmer will be responsible for hands-on programming and results delivery. Additionally, they will be responsible for manipulating large databases and generating reports to partner with 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
Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
Write, test, validate and execute department-, product- and protocol-level macros and utilities
Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
Participate in the recruitment of programming staff
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)
Manage staff performance and oversee staff assignments and utilization
Requirements:
Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least four (4) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Experience in SQL, and statistical programming using SAS or R
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 in 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)