Statistical Programmer II

Statistical Programmer II

Alexion Canada

Hybrid Work- 3 days from our Mississauga or Downtown (temporary) office

Summary:

As a Statistical Programmer II, you will be primarily responsible for coordinating various tools for collecting different types of data and ensuring databases are created and adjusted for the end user. You will also contribute to the development and maintenance of analysis and reporting applications. This role requires solving complex problems within your area and participating in a range of projects.

This is what you will do:

The Statistical Programmer II will be a primary resource for the development and validation of programs that create datasets conforming to Alexion and CDISC standards, as well as Tables, Listings, and Figures (“TLFs”) for analysis purposes. You will develop specifications to ensure that statistical programming elements align with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. You will support the Programming Lead and may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. Additionally, you will act as a mentor to Statistical Programmers and Associate Statistical Programmers, demonstrating a strong ability to integrate statistical concepts with SAS Programming efficiently and effectively.

You will be responsible for:

• Supporting the development of technical programming specifications for SDTM, ADS, or ADaM standards.

• Independently developing and/or validating programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications.

• Supporting the development and validation of technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.

• Independently developing and validating programs that generate tables, listings, figures/graphs using Alexion specifications.

• Managing external vendors and contract programmers.

• Providing project progress updates of programming activities.

• Reviewing, maintaining, and approving protocol-specific documents as necessary.

• Providing guidance and mentoring to peer, junior-level Programmers, and contract staff.

• Supporting project leadership ensuring that department standards are implemented in all studies.

• Contributing ideas and thoughts towards the optimization of standard operating procedures.

• Leading 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 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.

You will need to have:

• Minimum of 4 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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.