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 innovative technologies to advance statistical programming and reporting capabilities
- Stay current with emerging methodologies, technologies, and regulatory guidelines, and incorporate best practices into team workflows
- Provide leadership, mentorship, and technical guidance to statisticians and programmers, fostering a culture of continuous improvement and excellence
- Assist in developing and implementing AI-enabled technologies to streamline statistical workflows and build automated, reproducible reporting pipelines that enhance efficiency, quality, and traceability
- Manage self and other resources according to priorities
- Knowledgeable of developments in the field of statistics in drug development
- Contribute to the review and maintenance of Amgen policies, SOPs, and controlled documents to ensure ongoing compliance and alignment with regulatory standards
This position is currently located at Amgen India (Hyderabad).
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation.
Basic Qualifications:
- MSc or PhD in Statistics, Biostatistics, or related field.
- 8 years relevant industry experience
- Proven ability to apply statistical methods in clinical development.
- Strong programming skills in R and/or Python
- Experience with R Shiny or interactive reporting tools
Preferred Skills:
- Doctorate degree in Statistics/Biostatistics
- Experience in machine learning, real world data analytics, electronic health record data analysis, clinical trial simulation or related applications
- Life-cycle drug development experience
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
- Experience in the Obesity Therapeutic Area
.
