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Amgen is seeking a dedicated Biostatistical Senior Programmer to join our Center for Observational Research (CfOR) organization, based in Hyderabad, India. This crucial role involves leading a team of senior statistical programmers who will generate Real-World Evidence (RWE) to support Amgen products throughout the drug development lifecycle. This lead programming role will collaborate with teams across multiple time zones to oversee request fulfillment, clarify requirements, track projects, resolve issues, and deliver high-quality results. The Biostatistical Programming Manager will report to a locally based Director of Biostatistical Programming. The Senior Biostatistical Programmer will be responsible for both hands-on programming as well as guiding junior programmers. 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:
Support a statistical programming team conducting analyses supporting Amgen's Regulatory submission studies and projects
Coordinate with functional leads to prioritize workflow
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
Review key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.
Write and/or review programming plans and analysis dataset specifications
Represent the programming function and participate in multidisciplinary project team meetings
Lead and develop technical programming and process improvement initiatives within CfOR
Write, test and validate department-, product- and protocol-level macros and utilities
Provide input to and participate in 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 four (4) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Proficiency in SQL programming and SAS or R programming is required
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 and EHR databases
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Team management experience
Global collaboration experience
Python programming
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
Scientific / technical excellence
Oral and written communication, documentation skills