Biostatistical Programming Manager in 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