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Manager Biostatistics (Study Lead Statistician)

Amgen -
Hyderabad, Telangana

Apply Now

Job details

9 days ago

Qualifications

Statistics
Statistics
Doctoral degree
EHR systems
R
Master's degree
Machine learning
Data analytics
Leadership

Full job description

India - Hyderabad

JOB ID: R-245745 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 03, 2026 CATEGORY: Clinical

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 (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, this role contributes through accurate implementation of statistical analyses and ensures adherence to CfDA and regulatory standards.

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 to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Ensure statistics sections of the TMF are maintained and up-to-date
Communicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insights
Contributes to defining signal detection threshold
Manages self and collaborates closely with peers to ensure timely and quality deliverables
Reviews deliverables from external suppliers for quality
Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
Assisting in the review of Amgen Policies, SOPs, and other controlled documents
Contributing to process improvement initiatives and operational efficiencies.
Manage self and other resources according to priorities
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
Assist with the development and implementation of technology that utilizes AI to streamline statisticians' work.

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.
At least 8 years relevant industry experience for the Study Lead Statistician role.
Experience in machine learning
Life-cycle drug development experience
Experience working effectively in a globally dispersed team environment with cross-cultural partners.
Proven ability to apply statistical methods in clinical development.

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.

Apply Now

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