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?
AccountabilitiesSupport 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/ExperienceMinimum 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 problemsClearly communicate processes and standards with management and team membersHigh competence in using SAS/Base, SAS/Macro, SAS/STAT.Knowledge of SAS/Graph, and SAS/SQLKnowledge and implementation of:SDTM and ADaM principalsRelational 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
08-May-2025Closing Date
19-May-2025Alexion 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.