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

amgen; Hyderabad; On-site; INR 3,000,000 - 5,500,000; Full time

Job summary

Amgen India (Hyderabad) is expanding its global Biostatistics capabilities, with Amgen India playing a key role in integrated delivery and leadership. As a Biostatistics Manager, you will provide technical expertise and support the execution of statistical deliverables for clinical studies, ensuring adherence to regulatory standards.

You will collaborate cross-functionally to deliver robust analyses in TFLs, CSRs and publications, maintain TMF statistics, and drive process improvements while

Qualifications

• MSc or PhD in Statistics, Biostatistics, or related field.
• Minimum 5 years for Study Statistician role / 8+ years for Study Lead Statistician role.
• Experience applying statistics to clinical development and regulatory contexts.

Responsibilities

• Provide statistical contributions and QC of KDEs and protocols.
• Lead Clinical Study Team to execute trials per protocol and ensure data alignment.
• Contribute to SAPs, TFLs, CSRs and related study documents.
• Deliver robust analyses for tables, figures, listings and publications.
• Maintain TMF statistics and communicate study findings to stakeholders.
• Stay updated on statistics in drug development and Amgen policies.
• Support AI-enabled tools development to streamline statistics work.

Skills

Statistical analysis

Regulatory knowledge

Leadership

Cross-functional collaboration

Statistical programming

Education

MSc/PhD in Statistics/Biostatistics

Job description

Career Category

Clinical Development

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 (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 5 years relevant industry experience for Study Statistician role
• At least 8 years relevant industry experience for the Study Lead Statistician role.
• 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.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and develop within our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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