Senior Statistical Programmer Ii

Job Title Senior Statistical Programmer II Career Level D Introduction to role Are you ready to make a significant impact in the world of biopharmaceuticals As a Senior Statistical Programmer II you ll be at the forefront of developing and validating programs that create datasets conforming to Alexion and CDISC standards Your expertise will drive the creation of Tables Listings and Figures for analysis purposes Depending on the complexity of the study you may lead programming projects ensuring adherence to ICH guidelines Good Clinical Practices and regulatory requirements You ll also have the opportunity to mentor junior programmers and represent Statistical Programming in meetings with internal and external clients Are you prepared to integrate statistical concepts with SAS Programming efficiently and effectively Accountabilities Support development of technical programming specifications for SDTM ADS or ADaM standards Independently develop and or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications Support development and validate technical programming specifications for tables listings figures graphs based on Protocol and SAP Independently develop and validate programs that generate tables listings figures graphs using Alexion specifications Manage external vendors and contract programmers Provide project progress updates of programming activities Review maintain and approve protocol-specific documents as necessary Provide guidance and mentoring to peer junior-level Programmers and contract staff Support project leadership ensuring that department standards are implemented in all studies Contribute ideas and thoughts towards the optimization of standard operating procedures Lead team meetings when appropriate Essential Skills Experience Minimum of 6 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 High competence in using SAS Base SAS Macro SAS STAT Knowledge of SAS Graph and SAS SQL Knowledge and implementation of SDTM and ADaM principals Relational Databases Good Clinical Practice principals Good Programming Practice principals 21CFR Part 11 Standards principals Integrated Summary Safety Efficacy Analyses Safety data and Coding Dictionaries MedDRA and WHODD ICH eCTD format When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing medicines In-person working gives us the platform we need to connect work at pace and challenge perceptions That s why we work on average a minimum of three days per week from the office But that doesn t mean we re not flexible We balance the expectation of being in the office while respecting individual flexibility Join us in our unique and ambitious world At AstraZeneca you ll find a culture that values diversity and inclusion where new ideas are encouraged to flourish Our commitment to patients drives us to innovate continuously creating meaningful value in all we do You ll be part of a team that celebrates achievements while making a profound impact on patients lives With tailored development programs you ll grow both professionally and personally aligning your career with our mission to change lives for the better Ready to join a team that makes a difference Apply now Date Posted 28-Jul-2025 Closing Date 02-Aug-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