Biostatistics Manager (Study Statistician and/or Study Lead Statistician)

About the role

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As a Biostatistics Manager, you will provide technical expertise and support the execution of statistical deliverables for clinical studies, operating under guidance and contributing through accurate implementation of statistical analyses while adhering to CfDA and regulatory standards. The position is based in Hyderabad.

Key responsibilities

• Provide statistical contributions, review and quality control of study design documents, including Key Design Elements (KDE) and protocols
• Serve as the GBS lead on the Clinical Study Team Leadership Team, performing risk assessments and ensuring quality data collection aligned with study objectives
• Oversee statistical contributions to KDEs, protocols, randomization specifications, statistical analysis plans, tables, figures, listing shells, submission data file specifications and other study documentation
• Deliver robust, valid and scientifically rigorous analysis results in TFLs, Flash Memos, Clinical Study Reports, clinical publications and other communications
• Maintain statistics sections of the TMF and communicate study findings and insights with internal and external stakeholders
• Help define signal detection thresholds, manage self and collaborate with peers to meet quality and timeliness targets
• Review deliverables from external suppliers for quality, stay current on developments in statistics in drug development and assist in reviewing Amgen policies, SOPs and controlled documents
• Contribute to process improvement initiatives and help develop and implement technology using AI to streamline statisticians' work

Required profile

• MSc or PhD in Statistics, Biostatistics or a related field
• At least 5 years of relevant industry experience for the Study Statistician role, or 8 years for the Study Lead Statistician role
• Proven ability to apply statistical methods in clinical development
• Preferred: doctorate in Statistics/Biostatistics, life-cycle drug development experience, and experience in a globally dispersed, cross-cultural team

Required skills

• Application of statistical methods in clinical development
• Preferred: machine learning, real-world data analytics, electronic health record data analysis, clinical trial simulation

What we offer

• Vast opportunities to learn and develop within a global organization
• A diverse and inclusive community
• Total rewards plan covering health, finance and wealth, work/life balance and career benefits