Biostatistical Programming Manager in Hyderabad, भारत
Amgen
Full-timeStandard weekly hours
Hyderabad, भारत
Amgen seeks a Biostatistical Programming Manager to lead statistical programming teams and serve as Study Lead Programmer for clinical trials in Hyderabad, India. The role involves managing end-to-end study programming, establishing standards and timelines, and supporting regulatory submissions across integrated analyses.
Responsibilities
Lead one or more studies end-to-end as Study Lead Programmer with full accountability
Set programming strategy, establish timelines, and ensure quality and compliance of deliverables
Create and maintain SDTM, ADaM, and programming specifications for studies
Perform hands-on statistical programming for challenging deliverables and mentor team members
Represent Global Statistical Programming at Clinical Study Team meetings and cross-functional activities
Requirements
BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
Minimum 6 years statistical programming experience in clinical development
Deep knowledge of CDISC SDTM, ADaM, and Define standards with implementation expertise
Advanced SAS proficiency including SAS/STAT packages and data quality tools
Proven ability to lead and manage statistical programmers on study-level projects
Excellent project management and cross-cultural communication skills
Thorough understanding of clinical trial processes from data collection to reporting
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