Manager Biostatistics (Study Lead Statistician)

Career CategoryClinicalJob DescriptionHOW 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.Biostatistics ManagerWhat you will doLet’s do this. Let’s change the world.Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As a Biostatistics Manager, you will provide technical expertise and support the execution of statistical deliverables for clinical studies. Operating under guidance, this role contributes through accurate implementation of statistical analyses and ensures adherence to CfDA and regulatory standards.Responsibilities:Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocolsServe as the GBS lead on the Clinical Study Team Leadership Team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectivesOversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentationCollaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communicationsEnsure statistics sections of the TMF are maintained and up-to-dateCommunicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insightsContributes to defining signal detection thresholdManages self and collaborates closely with peers to ensure timely and quality deliverablesReviews deliverables from external suppliers for qualityStaying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the fieldAssisting in the review of Amgen Policies, SOPs, and other controlled documentsContributing to process improvement initiatives and operational efficiencies.Manage self and other resources according to prioritiesKnowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.Assist with the development and implementation of technology that utilizes AI to streamline statisticians' work.This position is currently located at Amgen India (Hyderabad).WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation.Basic Qualifications:MSc or PhD in Statistics, Biostatistics, or related field.At least 8 years relevant industry experience for the Study Lead Statistician role.Experience in machine learningLife-cycle drug development experienceExperience working effectively in a globally dispersed team environment with cross-cultural partners.Proven ability to apply statistical methods in clinical development.Preferred Skills:Doctorate degree in Statistics/BiostatisticsExperience in machine learning, real world data analytics, electronic health record data analysis, clinical trial simulation or related applicationsLife-cycle drug development experienceExperience working effectively in a globally dispersed team environment with cross-cultural partners..