Biostatistical Programming Senior Manager

Biostatistical Programming Senior Manager

• Full-time
• Screening Type:
  Phone Screen

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.

Job Description

Biostatistical Programming Senior Manager

Live

Let’s do this. Let’s change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. The Biostatistical Programming Senior Manager (Product Lead Programmer) lead a group of Oncology and other therapeutic area products. This Senior Manager will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas.

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.

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical Programming Senior Manager we seek is a leader with these qualifications.

• 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

• 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

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well‑being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and…