Biostatistical Programming Senior Associate
Location: Hyderabad, India (On-site)
Job ID: R-235518
Category: Clinical Development
Posted Date: February 02, 2026
Employment Type: Full-Time
Amgen is strengthening its global Statistical Programming organization, with Amgen India (AIN) playing a critical role in integrated delivery across regions. The Biostatistical Programming Senior Associate will support complex clinical studies and regulatory submissions through high-quality statistical programming and analysis. This role is ideal for experienced clinical programmers seeking to work on global programs within a highly collaborative, innovation-driven environment.
Perform statistical programming for the analysis and reporting of clinical trial data using SAS and/or R.
Create, validate, and maintain complex clinical datasets including SDTM, ADaM, and other analysis-ready datasets for both safety and efficacy domains.
Develop and validate Tables, Listings, and Figures (TLFs) in accordance with study requirements and regulatory standards.
Prepare and review statistical programming specifications and programming-related documentation for regulatory submissions.
Maintain complete tracking, validation, and quality control documentation to ensure compliance and audit readiness.
Collaborate with cross-functional teams to develop and validate programs for data quality checks and analyses.
Work closely with global study team members across functions to ensure timely and accurate delivery of outputs.
Support the Study Lead Programmer (SLP) and serve as a backup when required.
This position is based at Amgen India, Hyderabad.
Bachelor’s degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related quantitative or scientific discipline.
Minimum of 4 years of hands-on statistical programming experience in a clinical development or pharmaceutical research environment.
Strong understanding of the drug development lifecycle and clinical trial data standards.
Demonstrated expertise in manipulating, analyzing, and reporting complex clinical trial datasets.
Working knowledge of current CDISC standards, including SDTM, ADaM, and Define.xml, with proven ability to implement them.
In-depth experience with SAS, including SAS/STAT packages; exposure to R is an advantage.
Familiarity with data quality, validation, and compliance check tools.
Ability to manage multiple deliverables across studies while meeting tight timelines.
Excellent written and verbal communication skills in English.
Proven ability to work effectively in a globally distributed, cross-cultural team environment.
Master’s degree or higher in Statistics, Biostatistics, Mathematics, or a related field.
Experience with open-source programming tools (R, Python), automation frameworks, and emerging technologies in statistical programming.
Prior experience supporting regulatory submissions for drug approvals.
Amgen offers a collaborative and inclusive work culture focused on scientific excellence and patient impact. Employees benefit from continuous learning opportunities, career mobility across global teams, and a comprehensive rewards program covering health, financial well-being, work-life balance, and long-term career growth.
Apply through thepharmadaily.com to advance your career in global clinical statistical programming with a leading biopharmaceutical organization.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Tallinn |Hà Nội :
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Jeddah | Rabigh | Khulais | Riyadh | King Abdullah Economic City | Najran |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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Niš |Bohemia :
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