Senior Statistical Programmer

at  Alexion PharmaceuticalsInc

Location: Mississauga, Canada
Job reference: R-216877
Date posted: 01/10/2025
The Senior Statistical Programmer will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and CDISC standards, as well as Tables, Listings, and Figures (“TLFs”) for analysis purpose. They will develop specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. They will support the Programming Lead and may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. The Senior Statistical Programmer will act as a mentor to Statistical Programmers and Associate Statistical Programmers. HeTheyust demonstrate, at a minimum, a strong ability to comprehensively integrate statistical concepts with SAS Programming in a most efficient and effective manner.

• 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.
  The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.