Senior Manager Biostatistics

Senior Manager Biostatistics

remote type On Site

locations India - Hyderabad

time type Full time

posted on Posted Today

job requisition id R-253576

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