Amgen
Amgen is inviting applications for the position of Biostatistical Programming Associate at its India operations in Hyderabad. This opportunity is suitable for professionals with experience in statistical programming, clinical trial data analysis, and regulatory submissions.
Candidates with knowledge of SAS, R, CDISC standards, SDTM, and ADaM datasets can explore this opportunity to advance their careers in clinical development and biostatistical programming.
Job Details
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Company Name: Amgen
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Job Title: Biostatistical Programming Associate
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Job ID: R-248307
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Job Location: Hyderabad, Telangana
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Department: Global Statistical Programming
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Job Category: Clinical Research / Biostatistics
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Experience Required: At least 3 years
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Qualification: Bachelor’s degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related quantitative or scientific discipline
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Job Type: Not specified in the provided job description
Key Responsibilities
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Analyze and report clinical trial data using SAS and/or R.
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Create and validate SDTM, ADaM, and other analysis datasets for safety and efficacy.
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Develop and validate tables, listings, and figures (TLFs).
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Maintain tracking records and validation documentation.
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Develop and validate programs for data quality checks.
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Collaborate with cross-functional teams and global study team members.
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Support statistical analysis of Phase I–IV clinical studies and regulatory submissions.
Eligibility Criteria
Candidates should meet the following requirements:
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At least 3 years of statistical programming experience in a clinical development environment.
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Familiarity with the drug development lifecycle.
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Strong skills in clinical trial data manipulation, analysis, and reporting.
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Working knowledge of CDISC SDTM standards and familiarity with ADaM and Define standards.
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Familiarity with data quality and compliance-checking tools.
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Ability to manage multiple projects and meet challenging deadlines.
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Strong written and verbal English communication skills.
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Ability to collaborate effectively with global and cross-cultural teams.
Preferred Qualifications and Skills
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Master’s degree or higher in Statistics, Biostatistics, Mathematics, or a related discipline.
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Knowledge of open-source programming tools such as R and Python.
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Familiarity with automation platforms and emerging technologies in statistical programming.
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In-depth knowledge of SAS/STAT packages.
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Previous regulatory submission experience.
Benefits of Working at Amgen
Amgen highlights opportunities for professional growth and development, including:
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Career advancement opportunities across a global organization.
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An inclusive and collaborative work environment.
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Health and wellness benefits.
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Financial and wealth-related benefits.
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Work-life balance and other employee benefits.
How to Apply
Interested and eligible candidates can review the complete job description and submit their applications through the official Amgen careers website.
To apply for this job please visit careers.amgen.com.

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