Statistical Programming, Sr Manager

Amgen • Thousand Oaks, CA

4d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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 to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Statistical Programming, Sr Manager What you will do 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 Rare Disease and/or 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.

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

Nice To Haves

• 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

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.
• 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.

Benefits

• 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 accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed