Senior Manager, Biostatistical Programming

AmgenIndia - HyderabadonsiteSalary not postedView the original posting at Amgen ↗

Career Category Research Job Description Senior Manager, Biostatistical Programming HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Senior Manager, Biostatistical Programming What you will do Let’s do this. Let’s change the world. Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Senior Manager of Biostatistical Programming (Programming Execution Lead), you will partner with the Global Programming Lead (GPL) and lead an offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. Together with the GPL, this Senior Manager will be accountable and responsible for Global Statistical Programming study results and drug approval submission activities for the assigned product areas. Key Responsibilities: Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team. Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally. Plan and monitor progress of projects and address issues accordingly. 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 local programming staff. Provide input into career development plans for all staff on assigned projects This position will be located at Amgen India (Hyderabad). Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation. Basic Qualifications : BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment. Strong technical, communication, and leadership skills Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end Experience developing a successful offshore statistical programming team Flexibility and desire to work across different time-zones Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.) Prior regulatory submission experience for drug approval Thorough understanding and experience with data quality and compliance checks Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans) Experience working effectively in a globally dispersed team environment with cross-cultural partners Prior staff dev

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