Remote Biostatistical Programming Senior Manager

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