If you feel like youâre part of something bigger, itâs 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 worldâs leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Itâs time for a career you can be proud of. Join us.
Biostatistics Sr. Manager
What you will do
Letâs do this. Letâs 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 Amgenâs 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 statisticianâs work
This position is currently located at Amgen India (Hyderabad).
Win
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 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or
Masterâs degree in Statistics/Biostatistics or related subject with high statistical content and
At least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or
Bachelorâs 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
Preferred Skills:
Doctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or
Masterâs degree in biostatistics and at least 8 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 teammatesâ 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