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Manager - Oncology RWE Statistical Programming

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Amgen

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Location:
India , Hyderabad

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

Amgen is seeking a dedicated Biostatistical Programming Manager 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 Biostatistical Programming Manager 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:

  • 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
  • Project manage programming activities, according to agreed resource and timeline plans
  • Ensure programming activities adhere to departmental standards and SOPs
  • Write and/or review and approve 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 and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
  • Write, test, validate and execute department-, product- and protocol-level macros and utilities
  • Oversee the work of outsourced resources assigned to projects
  • 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 six (6) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects
  • Proficiency in SQL programming and SAS or R programming is required
  • 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
  • Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
  • Experience with Python programming
  • Experience with real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
  • 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)
  • Experience with CDISC (SDTM, ADaM)

Additional Information:

Job Posted:
March 20, 2026

Work Type:
On-site work
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