Summary
Join Amgen as a Biostatistical Programming Senior Manager and lead global statistical programming study results and submission activities for assigned product areas.
Requirements
- Doctorate degree and 2 years of statistical programming in Pharmaceutical industry experience
- Master’s degree and 6 years of statistical programming in Pharmaceutical industry experience
- Bachelor’s degree and 8 years of statistical programming in Pharmaceutical industry experience
- Associate’s degree and 10 years of statistical programming in Pharmaceutical industry experience
- High school diploma / GED and 12 years of statistical programming in Pharmaceutical industry experience
Responsibilities
- Ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate
- Lead a group of Oncology and other therapeutic area products
- Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally
- Plan and monitor progress of projects and address issues accordingly
- Support GSP Functional Service Provider (FSP) relationship and oversight; Ensure the product goals can be met via the FSP staff
- Provide GSP product level input to developing and managing resource plans and budgets for GSP
- Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
- Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
- Assist in study and system audits and inspections by internal and external bodies
- Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
- Provide hands-on support to the assigned product areas as required
- Provide coaching and mentoring to staff
- Provide input into career development plans for all staff on assigned projects
Preferred Qualifications
- In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
- Advanced SAS analysis and reporting skills
- Prior regulatory submission experience
- Thorough understanding and experience with data quality and compliance checks
- Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
- Familiar with R Programming language
- Statistical programming experience in a clinical development environment
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
- Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end
- Prior staff development leadership and project management experience
- Excellent oral and written communication skills
- Ability to effectively perform complex statistical programming and related tasks
Benefits
- 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
