Statistical Programming, Sr Manager

About the role

Join Amgen’s mission of serving patients. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines.

Responsibilities

• Ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.
• Lead a group of Rare Disease and/or other therapeutic area products, setting and driving 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.

Requirements

• Doctorate degree and 2 years of statistical programming in Pharmaceutical industry experience OR Master’s degree and 6 years of statistical programming in Pharmaceutical industry experience OR Bachelor’s degree and 8 years of statistical programming in Pharmaceutical industry experience OR Associate’s degree and 10 years of statistical programming in Pharmaceutical industry experience OR High school diploma / GED and 12 years of statistical programming in Pharmaceutical industry experience

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 life cycle (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

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possible