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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:
Support a statistical programming team conducting analyses supporting Amgen's Regulatory submission studies and projects
Provide technical solutions to programming problems within CfOR
Ensure the analysis and presentation of biomedical data is accurate and complete
Adhere to Amgen policies, SOPs and other controlled documents
Write, test, and validate programs in SAS, Databricks, or R to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications, and other internal and external communications
Complete programming activities, according to agreed resource and timeline plans
Create key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.
Write programming plans and analysis dataset specifications
Develop technical programming and process improvement initiatives within CfOR
Write, test and validate department-, product- and protocol-level macros and utilities
Provide input for intra-departmental and CfOR meetings
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
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
Proficiency in SAS and SQL programming
Experience with R and Python is preferred
Scientific and technical excellence
Exceptional oral and written communication skills
Problem-solving abilities
Meticulous attention to detail
Ability to work effectively within a large, globally distributed team
Nice to have:
Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Global collaboration experience
CDISC (SDTM, ADaM) knowledge
Agile project management
Knowledge of real-world data (RWD) including insurance claims databases, electronic medical records and patient registries
Knowledge of drug development life cycle
Statistics and basic epidemiology: Incidence and prevalence