Biostatistics Sr Mgr

Biopharma Careers; Hyderabad; On-site; INR 3,500,000 - 5,200,000; Full time

Job summary

Amgen India in Hyderabad seeks a Senior Biostatistics Manager to lead statistical strategy across clinical development and regulatory submissions. You will guide analyses, contribute to study design and oversee a team of statisticians in a global setting.

The ideal candidate combines advanced statistical expertise with leadership and a passion for transforming patient outcomes through data-driven decisions.

Qualifications

• Doctorate or Master’s with substantial statistical content and extensive industry experience in pharma/medical research.
• Experience leading statistical contributions to protocols, CSRs, and regulatory submissions.
• Strong communication and leadership in cross-functional, global teams.

Responsibilities

• Provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
• Plan and execute statistics contributions to protocols, CSRs and related documents.
• Oversee design, analysis plans and listings for trials; ensure quality and consistency of statistical outputs.
• Lead cross-functional collaboration to deliver robust TFLs, CSRs and publications.

Skills

Biostatistics

Clinical development

Statistical analysis

Regulatory submissions

Leadership

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

BS 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 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 andAt least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Master’s degree in Statistics/Biostatistics or related subject with high statistical content andAt least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Bachelor’s degree in Statistics/Biostatistics or related subject with high statistical content andAt 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
• 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.

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