Biostatistics Sr Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistics Sr Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.

Accountabilities

•Provide dedicated support for Exploratory Biostatistics

•Execute key projects, deliverables and operational tasks related to exploratory biostatistical strategy, technical expertise, and reporting within designated studies / products

•Execute statistics strategy, implement standards and approaches to ensure quality and technical excellence in strategy, exploratory analysis planning, and statistical analyses

•Advise and manage statisticians on best practices and techniques for exploratory analysis to align with industry standards and to provide valid, robust conclusions

•Opportunity to serve as the product or disease area exploratory analysis lead, as needed

Responsibilities

Statistical Excellence

•Utilize knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, clinical trial biomarker (CTA) and companion diagnostics (CDx) co-development, and precision Medicine organization.

•Plan and execute statistical activities contributing to exploratory statistical analysis plans, reports and publications

•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 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 EBG lead on the Evidence Generation Team (EGT) or Clinical Study Team (CST) with exploratory analysis needs to support Precision Medicine or drug/CDx codevelopment

•Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study

•Provide statistical consultancy, training, and advice within Amgen

•Contribute to process improvement initiatives and operational efficiencies

•Oversee FSP statisticians and check their contributions for quality

•Opportunity to manage staff, e.g.external contractors