Biostatistics Sr Mgr

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

Job summary

Amgen India (Hyderabad) is seeking a strategic Biostatistics leader to guide statistical strategy across clinical development, reimbursement and medical affairs. You will oversee study design and analysis, mentor staff, and collaborate with global teams to deliver rigorous, timely results.

The role requires advanced degrees with extensive post-graduate experience and a track record in regulatory submissions. Join a global company advancing patient outcomes.

Qualifications

• Doctorate with high statistical content and 8+ years in pharma or medical research.
• Or Master's with 10+ years of post-graduate statistical experience.
• Or Bachelor's with 14+ years of post-graduate statistical experience.

Responsibilities

• Inform and provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
• Plan and execute statistical contributions to protocols, Flash Memos and CSRs.
• Implement and support standards in study design and statistical analysis.
• Stay updated on developments in statistics and Amgen policies.
• Communicate innovative statistical methodologies and trial design.
• Oversee TS contributions to design elements and data listings.
• Collaborate cross-functionally to deliver robust analyses (TFLs, FM, CSRs).
• Serve as GBS lead on the Clinical Study Team to execute trials per protocol.
• Contribute to publications, regulatory filings, and reimbursement documents.
• Provide statistical consultancy and training within Amgen.
• Contribute to process improvement and operational efficiencies.
• Oversee FSP statisticians and ensure TMF quality.
• Lead technology adoption leveraging AI to streamline work.

Skills

Biostatistics leadership

Statistical leadership

Cross-functional collaboration

Strategic thinking

Regulatory-submission support

AI-enabled transformation

Education

Doctorate in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Bachelor's in Statistics/Biostatistics

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 Sr. Manager

What You Will Do

Let’s do this. Let’s change the world.

Responsibilities

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.


• Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)


• Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.


• Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen's statistical policies, procedures and strategies.


• Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product


• 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


• 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


• Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study


• Provide statistical consultancy, training, and advice within Amgen


• Contributing to process improvement initiatives and operational efficiencies.


• Oversee FSP statisticians and check their contributions for quality


• Ensure statistics sections of the TMF are maintained and up‑to‑date


• Opportunity to manage staff


• Contribute to and lead technology adoption leveraging AI capabilities to streamline statistician's 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

• Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and


• At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or

• Master's degree in Statistics/Biostatistics or related subject with high statistical content and


• At least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or

• Bachelor's degree in Statistics/Biostatistics or related subject with high statistical content and


• At least 14 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Preferred Skills

• Doctorate degree in biostatistics and at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or

• Master's degree in biostatistics and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research


• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)


• Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity


• Statistical leadership and contribution to regulatory and reimbursement submissions. of regulatory guidelines.


• Experience working effectively in a globally dispersed team environment with cross-cultural partners.

Thrive

What You Can Expect Of Us

• 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