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Principal CMC Statistician

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Amgen

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Location:
India , Hyderabad

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Category:
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Contract Type:
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Salary:

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Job Description:

Join Amgen’s Mission of Serving Patients. Contribute to Amgen’s pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives. The Principal CMC Statistician will use their expertise to implement statistical tools and techniques with science-based practices used throughout the product life cycle.

Job Responsibility:

  • Implement statistical tools and techniques with science-based practices used throughout the product life cycle
  • Provide multi-functional support to clinical and commercial manufacturing sites in the network including statistical support for activities such as process characterization and monitoring programs, analytical methods, specifications, and investigations
  • Support the development of delivery devices, providing statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification and transfer of physical test methods
  • Establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing
  • Support continuous improvement efforts across Amgen’s networks, leading to harmonization, efficiency gains and scientific innovation
  • Administration of statistical training for Amgen’s engineers and scientists
  • Act as a technical lead in the development, implementation and maintenance of statistical tools used to support product life cycle activities
  • Provide continuous statistical support to a site or functional group
  • Support regulatory audits
  • Participate in improvement efforts to promote statistical techniques used in biologics and monoclonal antibodies processes
  • Mentor and guide statistical techniques and software tools to technical associates
  • Stay up to date on biotechnology industry trends, standard processes, guidance documents and participates in external conferences

Requirements:

  • Doctorate Degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 2 years of applied statistics experience
  • Master’s Degree in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 8 to 10 years of applied statistics experience
  • Bachelor’s Degree in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 10 to 14 years of applied statistics experience
  • Diploma in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 14 to 18 years of applied statistics experience

Nice to have:

  • Post-graduate degree with 6+ years’ experience in Biopharma manufacturing and control
  • Proficient in statistical tools and techniques commonly used in biopharma manufacturing operations, such as, Design of Experiments, Statistical Process Control, Process Capability Analysis, Measurement System Analysis, Acceptance Sampling Plans, Non-linear and Linear Regression, Significance Tests, and Simulation
  • Proficient in SAS and/or R programming (data manipulation techniques, macro, statistical and graphical PROCs, and ODS) and JMP statistical software
What we offer:
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Additional Information:

Job Posted:
January 06, 2026

Work Type:
On-site work
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