Biostatistical Programming Manager

Career Category Research Biostatistical Programming Manager 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 Biostatistical Programming Manager 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 Biostatistical Programming Manager you will serve as the Study Lead Programmer SLP for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study You may also support regulatory submissions Key Responsibilities Lead one or more than one study project end to end and assume all the responsibilities of Study Lead Programmer Set the programming strategy for the studies and projects and ensure timelines quality and compliance of all deliverables Lead and manage specific programming tasks e g all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions assigned to the team Participate in establishing the programming scope for a deliverable with the statisticians and the study team Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project Create and maintain programming related specifications e g SDTM and ADaM for the studies projects Represent GSP at the Clinical Study Team CST Attend meetings for and provide programming input into cross-functional study start-up activities including but not limited to CRF development database specifications review database development IVRS specification review data quality check specifications Initiate cross-functional team meetings as necessary Perform significant hands-on statistical programming particularly for those most challenging deliverables Manage individual programmer work assignments to ensure timely high-quality deliverables Provide technical leadership and guidance for study programming team Coordinate and monitor data issue reporting and resolution Coordinate with other SLPs to providing consistent deliverables across studies within a product Manage technical aspects of project e g create manage computing environment lookup tables etc Provide training and guidance to other programmers Assume some product level responsibilities as delegated by Global Programming Lead GPL and or Programming Execution Lead PEL 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 6 years of statistical programming experience in clinical development environment Thorough understanding of clinical trial processes from data collection to analysis reporting Proven record of superior statistical programming and problem-solving skills within clinical development environment Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities including preparing data and programming specifications for a study end-to-end In-depth knowledge on latest CDISC SDTM ADaM and Define standards along with strong ability to implement all aspects of those standards Advanced analysis and reporting skills in SAS including SAS STAT packages among others Experience in data quality and compliance check tools Excellent project management skills and ability to lead multiple projects effectively Excellent oral and written English communication skills Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners Willingness and ability to provide guidance to team members on technical and process questions Preferred Skills MSc or higher degree in statistics biostatistics mathematics or related quantitative or scientific subjects Familiarity with open-source programming tools R Python automation platforms and emerging technologies in statistical programming Prior regulatory submission experience for drug approval 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