[02/10/2025] Associate Director, Biostatistical Programming

Career Category Research Associate Director 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 Associate Director 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 an Associate Director of Biostatistical Programming Programming Execution Lead you will partner with Global Programming Leads GPL and lead a large offshore team of Study Lead Programmers SLP and Study Programmers SP to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large high priority products or indications across products Together with GPL this Associate Director will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned products or indications across products The Associate Director of Biostatistical Programming will contribute at the department level by leading major GSP technical or operational efficiency initiatives and ensuring compliance with R D standards leading or serving as a member of GSP and cross functional consultancy groups such as Submission Consultancy Group and ADaM Consultancy Group The Associate Director will drive the piloting and integration of new technologies including artificial intelligence statistical programming automation tools and open-source platforms to improve quality and efficiency across the organization Key Responsibilities Accountable and responsible for ensuring successful execution and delivery of GSP milestone analysis deliverables and regulatory submission packages for a group of high priority and or high complexity 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 products 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 Drive the piloting and integration of new technologies including artificial intelligence statistical automation tools and open-source platforms to improve functional maturity and efficiency Lead and or participate in departmental process improvement initiatives and cross-functional working groups Represent GSP 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 GSP staff globally Provide input into career development plans to direct reports and 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 10 years of statistical programming experience in clinical development environment Strong technical communication and leadership skills Ability to lead and manage a large team of programmers in successful and timely completion of all programming activities for highly complex studies and regulatory submissions 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 and others or R Prior regulatory submission experience for approval Thorough understanding and experience with data quality and compliance checks Experience working effectively in a globally dispersed team environment with cross-cultural partners Prior staff development leadership and project management experience Excellent oral and written English communication skills Ability to effectively perform complex statistical programming and related tasks Preferred Skills MSc or higher degree in statistics biostatistics mathematics or related quantitative or scientific subjects Familiarity with open-source programming tools e g R Python automation platforms and emerging technologies in statistical programming Thrive What you can expect of us As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health finance and wealth work life balance and career benefits