Biostatistics Manager

This role provides an opportunity to gain breadth across statistical deliverables while developing depth in clinical trial methodology, programming, and cross-functional teamwork.

Responsibilities:

• Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols
• 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
• 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
• Ensure statistics sections of the TMF are maintained and up-to-date
• Communicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insights
• Contributes to defining signal detection threshold
• Manages self and collaborates closely with peers to ensure timely and quality deliverables
• Reviews deliverables from external suppliers for quality
• Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
• Assisting in the review of Amgen Policies, SOPs, and other controlled documents
• Contributing to process improvement initiatives and operational efficiencies.
• Manage self and other resources according to priorities
• Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
• Assist with the development and implementation of technology that utilizes AI to streamline statisticians' work.

Win

What we expect of you

Basic Qualifications:

• MSc or PhD in Statistics, Biostatistics, or related field.
• ~3–5 years relevant industry experience.
• Proven ability to apply statistical methods in clinical development.

Preferred Skills:

• Doctorate degree in Statistics/Biostatistics
• Experience in machine learning, real world data analytics, electronic health record data analysis, clinical trial simulation or related applications
• Life-cycle drug development experience
• 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 move up and across 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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