Senior Director, Biostatistics

Career Category
Research 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Senior Director, Biostatistics
What you will do

Let’s do this. Let’s change the world. In this vital role you will provide strategic statistical input to and oversees all statistical aspects of biosimilar development for all products; leads, manages and develops the team of biosimilars biostatisticians; oversees the performance of biostatisticians in Contract Research Organizations (CROs); enhances statistical understanding within Biosimilar Development; develops innovative methodologies and study designs for biosimilars; and assists the head of Biostatistics and Statistical Programming in leading the department.
Responsibilities

- Provide oversight for protocols, Statistical Analysis Plans, Flash Memos/Summary of Report, Clinical Study Reports, submission documents, correspondences with health authorities, clinical publications, reimbursement documents and other communications.

- Develops and maintains successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development. Provides strategic statistical input and is a major contributor to clinical development plans.

- Ensures standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis; maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results; and contributes to statistical strategy in Amgen 's Biosimilar Development.

- Ensures excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentation/publication. Represents Biosimilar Development on statistical matters at meetings with regulatory authorities, key opinion leaders and similar other expert bodies and defends statistical approaches internally and externally.

- Provides oversight and guidance to staff members within Amgen and in CROs in completing study deliverables according to agreed timelines following quality standards.

- Responsible for hiring, allocation, management, and development of internal statistical staff, and contributes to developing and managing goals, budgets and resource plans.

- Leads and/or participates in the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen 's Biosimilar Development for process improvement and operational efficiency.

- Promotes, communicates, and becomes an expert in specific statistical methodologies. Publishes applied research in scientific journals and books and gives presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings. Stays abreast of and contributes to scientific advances in the field.