Safety Statistician, Senior Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s 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 world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Safety Statistician, Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. Amgen’s Center for Design and Analysis Organization has a new opportunity for a Safety Statistician, Senior Manager to provide independent statistical expertise on safety assessment activities in support of FDA safety reporting requirements. In this vital role, you will independently lead the statistical activities related to the assessment of aggregate safety data for multiple studies/products. You will be part of a cross-functional team, which will provide clinical and statistical judgment to evaluate the totality of the information related to specific adverse events (including different indications, patient populations, study designs, dosing schedules, follow-up durations). You will ensure that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically accurate, influence and contribute to the process development and defend statistical approaches internally and externally. As a Safety Statistician, Senior Manager, you will

• Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams in aggregate safety assessment and reporting.
• Provides statistical expertise on aggregate safety assessment and reporting activities supporting the FDA/IND final rule.
• Authors and provides statistical leadership on aggregated safety analysis plans (AP) across multiple studies/products.
• Performs aggregate safety statistical analyses of multiple studies/projects and subsequent exploratory analyses and makes sound conclusions and recommendations.
• Implements, oversees and supports standards, technical quality and consistent approaches in strategy, statistical analysis for safety assessment.
• Anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
• Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines.
• Stays abreast of latest developments in the field of statistics in drug development (innovative trial design), notably in the field of aggregate safety assessment and reporting.
• Adheres to all Amgen Policies, Standard operation procedures (SOPs).

Responsibilities may include:

• Provide statistical expertise to Centralized Statistical Monitoring and Quality Tolerance Limit projects
• Plans and executes statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
• Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
• Oversees statistical work performed by study statisticians.

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 2 years of experience OR

• Master’s degree and 4 years of experience OR

• Bachelor’s degree and 6 years of experience OR

• Associate’s degree and 10 years of experience OR

• High school diploma / GED and 12 years of experience

Preferred Qualifications:

• Technically strong with hands on experience of various design and statistical analysis
• Clinical trial experience
• Any safety assessment experience and/or experience of application of Bayesian methodology in clinical trials environment is a plus
• Experience working effectively in a globally dispersed team environment with cross-cultural partners