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Associate - RWE Regulatory Statistical Programming

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Amgen

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Location:
India , Hyderabad

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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Job Description:

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
  • Leadership
  • Innovation

Additional Information:

Job Posted:
March 04, 2026

Work Type:
On-site work
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