**Job Title: Principal Statistical Programmer**

**Overview:**
The Principal Statistical Programmer will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and ADaM specifications, as well as Tables, Listings, and Figures (“TLFs”) for analysis of efficacy data. This role requires expertise in integrating statistical concepts with SAS Programming efficiently and effectively.

**Key Responsibilities:**
- Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
- Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
- Develop and validate specifications for protocol-specific efficacy tables, listings, and figures/graphs based on Protocol SAP.
- Supervise and manage external vendors and contract programmers, overseeing progress of programming activities.
- Review, maintain, and approve protocol-specific documents as necessary.
- Provide guidance and mentoring to peer and junior-level Programmers.
- Act as the primary department contact to ensure adherence to department standards in all studies.
- Contribute ideas towards the optimization of standard operating procedures.

**Qualifications:**
- Bachelor’s Degree (Minimum) or Master’s Degree (Preferred) in Biostatistics, Statistics, or a related discipline.
- Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
- Proven track record in developing and validating specifications and programs for safety and efficacy analysis datasets.
- Expertise in SAS/Base, SAS/Macro, and SAS/STAT; knowledge of SAS/Graph and SAS/SQL.
- Familiarity with SDTM and ADaM, Good Clinical Practices, and 21CFR Part 11 Standards.

**About Alexion Canada:**
Since 2009, Alexion Canada has been dedicated to bringing innovative medicines to Canadians living with rare diseases. Our commitment to patient-centric decision-making and a collaborative work environment drives us to find and access therapies that transform lives.

**Work Culture:**
Alexion promotes diversity, equality, and inclusion within our teams. We are committed to accommodating persons with disabilities during the recruitment process.

**Application Instructions:**
Interested applicants are encouraged to apply to join our team.

**Note:**
All applications will be reviewed after our office closure from December 25th to January 1st, re-opening January 2nd.