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 rare disease biopharma? As a Senior Statistical Programmer II, youll be at the forefront of developing and validating programs that create datasets conforming to Alexion and CDISC standards. You will play a pivotal role in generating 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. Your expertise will guide and mentor junior programmers, while your ability to integrate statistical concepts with SAS Programming will drive efficiency and effectiveness. Are you prepared to take on this challenge? 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. Any other activities as required. 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 principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, youll find yourself immersed in a culture that thrives on innovation and collaboration. Our commitment to transforming complex biology into transformative medicines is unwavering. With a rapidly expanding portfolio in rare disease biopharma, youll have the chance to grow and innovate alongside exceptional leaders and peers. Our entrepreneurial spirit fosters autonomy and connection, empowering you to explore new ideas while meeting the needs of under-served patients worldwide. Here, your career is not just a path but a journey to making a difference where it truly counts. Ready to embark on this exciting journey with us? Apply now to join our team! 04-Jun-2025 04-Jun-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 accommodations@Alexion.com . Alexion participates in E-Verify.