Senior Manager Biostatistics

Biopharma Careers; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Amgen India (Hyderabad) is seeking a Biostatistics Sr. Manager to lead study-level statistical deliverables with substantial independence and to mentor staff.

You will oversee FSP statisticians, ensure high-quality outputs for protocols, CSRs, and regulatory submissions, and collaborate cross-functionally with global teams to drive strategic medical decisions. Join a global organization that values scientific leadership, innovation, and career development while contributing to medicines that

Qualifications

• Doctorate degree in Statistics/Biostatistics or related subject with high statistical content
• 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
• At least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Responsibilities

• Inform and provide statistical guidance to cross-functional areas 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, quality and consistency in design, analysis and strategy.
• Knowledgeable about developments in statistics for drug development and Amgen's policies and strategies.
• Oversee statistical contributions to design elements, randomization specifications, SAPs, TFLs, and listings.
• Collaborate cross-functionally to deliver robust analysis results for submissions and publications.
• Provide statistical consultancy, training, and advice within Amgen and lead process improvements.

Skills

Statistical leadership

Cross-functional collaboration

Regulatory knowledge

Education

Doctorate in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Job description

Career Category

Research

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.

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As a Biostatistics Sr. Manager, you will lead study-level statistical deliverables with substantial independence. This role manages small teams, mentors staff and ensures the delivery of high-quality statistical outputs that meet CfDA and regulatory expectations.

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, e.g. external contractors
• Opportunity to serve as a GSL for a product program
• Opportunity to serve as a product regional lead
• Contribute to and lead technology adoption leveraging AI capabilities to streamline statistician's work

This position is currently located at Amgen India (Hyderabad).

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 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Preferred Skills

• Doctorate degree in biostatistics and at least 8 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

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