Biostatistical Programming Senior Manager
| Company | Amgen |
|---|---|
| Location | United States |
| Salary | $153890 – $179170 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD, Associate’s |
| Experience Level | Senior, Expert or higher |
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
- Accountable and responsible for Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen 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