Manager Biostatistics (Study Lead Statistician)

Amgen Inc. (IR); Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Amgen India in Hyderabad is seeking a Biostatistics Manager to provide technical expertise and support statistical deliverables for clinical studies. You will contribute to KDEs, protocols, TFLs, and CSRs while ensuring regulatory compliance and data integrity.

The role requires 8+ years in the field, proficiency in machine learning, and experience in global, cross-cultural teams. You will help advance drug development and support AI-enabled statistics initiatives.

Qualifications

• MSc or PhD in Statistics, Biostatistics, or related field.
• 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.

Responsibilities

• Provide statistical contributions and QC of study design documents, including KDEs and protocols.
• Lead the Clinical Study Team Leadership Team to execute trials according to protocol and ensure data quality.
• Oversee statistics contributions to SAPs, listings, and submission data file specs.
• Collaborate cross-functionally to deliver robust analyses (TFLs, CSRs, publications).
• Maintain statistics TMF sections and communicate findings to stakeholders.
• Stay updated on statistics developments and AI-enabled workflows.

Skills

Statistical analysis

Clinical study design

Cross-functional collaboration

Regulatory compliance

Education

MSc/PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

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 (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.

• 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).

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen