5. Biostatistical Programming Assoc Dir

Career Category Strategy and Innovation 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Biostatistical Programming Associate Director 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 Associate Director (Global Programming Lead) leads a group of Oncology and/or other therapeutic area products. This Associate Director will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas. Provides strategic leadership for high priority products or indications across products. Leads large programming team and defines end to end programming strategy to ensure submission and inspection readiness. Accountable and responsible for Global Statistical Programming (GSP) deliverables and submission activities for large products with large scale submissions. Aligns priorities with GSP TA Head, Global Statistical Lead and cross-functional teams. Leads GSP operational efficiency and ensures compliance with R&D standards. Leads and/or contributes to departmental process, system and technology improvement initiatives and cross-functional working groups. Be able to lead big initiatives, or define/author key processes and controlled documents, or expertise in related areas. Develops department analysis and reporting standards in partnership with cross functional teams. Represents GSP in audits and inspections by internal and external bodies, and provides input and advice on responses to findings. Provides coaching and mentoring to Amgen staff. What we expect of you We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills: Basic Qualifications: Minimum bachelor’s degree in a quantitative or scientific field and 9 years of statistical programming experience in pharmaceutical industry. Prefer master’s degree in statistics, biostatistics, or mathematics and 10 years of statistical programming experience in pharmaceutical industry OR Doctorate degree in statistics, biostatistics, or mathematics and 5 years of statistical programming experience in pharmaceutical industry. Preferred Qualifications: Advanced SAS analysis and reporting skills. In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL. Prior regulatory submission experience. Prior product/compound level statistical programming leadership 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). Familiarity with other programming languages (e.g. R, Python). 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, mentorship, people management and project management experience. Excellent oral and written English 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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. LOCATION: Ability to work fully remote, or, if situated near an office, the option to work flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. .