BiostatisticsManager

## **Career Category** Clinical ## ## **Job Description** **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission -to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. **Biostatistics Manager** **What you will do** Let’s do this. Let’s change the world. Amgen is expanding its global Biostatistics capabilities, with Amgen India 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, this role contributes through accurate implementation of statistical analytics within data visualization tools you create and ensures adherence to CfDA and regulatory standards. **Responsibilities:** * Lead and oversee the application of biostatistical methods to analyze and interpret clinical trial data across multiple studies or programs, ensuring scientific rigor and consistency * Provide strategic direction and oversight for statistical programming using R and Python, enabling scalable, efficient, and compliant data analysis and reporting solutions * Manage and review the development of tables, listings, and figures (TLFs), as well as outputs supporting clinical study reports, publications, and regulatory submissions * Ensure compliance with regulatory requirements, industry standards (including CDISC SDTM and ADaM), internal quality processes, and support audits and inspections as needed * Collaborate with cross-functional teams to ensure timely delivery of study outputs * Identify, prioritize, and implement process improvements, tools, and innovativ