Statistical Programming, Sr Manager

Statistical Programming, Sr Manager 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) leads a group of Rare Disease and/or other therapeutic area products, accountable for Global Statistical Programming study results and submission activities for 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 develop and manage resource plans and budgets for GSP. Efficiently 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. Basic Qualifications Doctorate degree and 2 years of statistical programming in pharmaceutical industry experience. Masters degree and 6 years of statistical programming in pharmaceutical industry experience. Bachelors 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. 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. 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. 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. 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. #J-18808-Ljbffr BioSpace