Principal Statistical Programmer

Job Title Principal Statistical Programmer Introduction to role Are you ready to make a significant impact in the world of biopharmaceuticals As a Principal Statistical Programmer you ll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications Your expertise will drive the analysis of efficacy data through Tables Listings and Figures TLFs You ll ensure compliance with ICH guidelines Good Clinical Practices and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients As a mentor to other Statistical Programmers you ll integrate statistical concepts with SAS Programming efficiently and optimally Accountabilities Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications Build and validate technical programming specifications for protocol-specific efficacy tables listings figures graphs based on Protocol SAP Independently develop and validate programs that generate efficacy tables listings figures graphs using Alexion specifications Supervise manage external vendors and contract programmers Be responsible for progress of programming activities Review maintain and approve protocol-specific documents as vital Provide guidance and mentoring to peer and junior-level Programmers Act as the primary department contact to ensure implementation of department standards in all studies Contribute ideas towards the optimization of standard operating procedures Lead team meetings when appropriate Engage in any other activities as required Essential Skills Experience Bachelor s Degree Minimum or Master s Degree or equivalent experience Preferred in Biostatistics Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical Biotechnology or Contract Research Industry Proven ability to Develop and validate technical specifications and programs for safety and efficacy analysis datasets tables listings and figures graphs Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS Base SAS Macro SAS STAT Knowledge of SAS Graph and SAS SQL Desirable Skills Experience SDTM and ADaM Relational Databases Good Clinical Practices Good Programming Practices 21CFR Part 11 Standards Integrated Summary Safety Efficacy Analyses Safety data and Coding Dictionaries MedDRA and WHODD ICH eCTD format At AstraZeneca s Alexion division you ll find a unique opportunity to work in a company where Here it means more is an ethos that drives us Our pioneering spirit in R D and healthcare sets us apart allowing you to grow and innovate within a rapidly expanding portfolio You ll be part of an energizing culture that fosters connections exploration of new ideas and learning As a member of our team you ll meet the needs of under-served patients worldwide while being empowered with tailored development programs Our dedication to diversity innovation and connection to patients lived experiences ensures your career journey is impactful Ready to make a difference Join us at AstraZeneca s Alexion division today Date Posted 11-Jul-2025 Closing Date 23-Jul-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy including childbirth breastfeeding or related medical conditions parental status including adoption or surrogacy military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law Alexion provides reasonable accommodations to meet the needs of candidates and employees To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in E-Verify