Statistical Programming, Sr Manager

Career Category Clinical Job Description 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. Win What we expect of you 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. Basic Qualifications: 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 What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. 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 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 151,838.05USD -205,427.95 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit and follow us on