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Biostatistical Programming Manager

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Amgen

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Location:
India , Hyderabad

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Category:
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Salary:

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Job Description:

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Manager, you will serve as the Study Lead Programmer (SLP) for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study. You may also support regulatory submissions.

Job Responsibility:

  • Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
  • Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
  • Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team
  • Participate in establishing the programming scope for a deliverable with the statisticians and the study team
  • Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
  • Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects
  • Represent GSP at the Clinical Study Team (CST)
  • Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications
  • Initiate cross-functional team meetings as necessary
  • Perform significant hands-on statistical programming, particularly for those most challenging deliverables
  • Manage individual programmer work assignments to ensure timely, high-quality deliverables
  • Provide technical leadership and guidance for study programming team
  • Coordinate and monitor data issue reporting and resolution
  • Coordinate with other SLPs to providing consistent deliverables across studies within a product
  • Manage technical aspects of project (e.g., create/manage computing environment, lookup tables, etc.)
  • Provide training and guidance to other programmers
  • Assume some product level responsibilities as delegated by Global Programming Lead (GPL) and/or Programming Execution Lead (PEL)

Requirements:

  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 6 years of statistical programming experience in clinical development environment
  • Thorough understanding of clinical trial processes, from data collection to analysis reporting
  • Proven record of superior statistical programming and problem-solving skills within clinical development environment
  • Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end
  • In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
  • Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others
  • Experience in data quality and compliance check tools
  • Excellent project management skills and ability to lead multiple projects effectively
  • Excellent oral and written English communication skills
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Willingness and ability to provide guidance to team members on technical and process questions

Nice to have:

  • MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
  • Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
  • Prior regulatory submission experience for drug approval
What we offer:
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Additional Information:

Job Posted:
March 21, 2026

Work Type:
On-site work
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