Biostatistics Manager

•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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is adept with these qualifications.

Basic Qualifications

Preferred Qualifications  

•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, we also work to care for our teammates’ professional and personal growth and well-being. 

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors, including but not limited to, relevant skills, experience, and qualifications. 

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: 

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. 

• A discretionary annual bonus program. 

• Stock-based long-term incentives. 

• Award-winning time-off plans and bi-annual company-wide shutdowns. 

• Flexible work models, including remote work arrangements, where possible. 

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.