**Job Title: Principal Statistical Programmer**

**Job Description:**

The Principal Statistical Programmer will be a primary resource for the development and validation of programs that create datasets conforming to Alexion and ADaM specifications, as well as Tables, Listings, and Figures (TLFs) for the analysis of efficacy data. Responsibilities include:

- Developing specifications to ensure that statistical programming elements align with overall deliverables.
- Ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.
- Serving as a Programming Lead and representing Clinical and Statistical Programming in meetings with internal and external clients and cross-functional project teams.
- Acting as a mentor to other Statistical Programmers.

**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 specifications.
- Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, and figures/graphs based on Protocol SAP.
- Manage external vendors and contract programmers.
- Oversee progress of programming activities and review, maintain, and approve protocol-specific documents as necessary.
- Provide guidance and mentoring to peer and junior-level Programmers.
- Contribute ideas towards optimizing 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.

**Required Skills:**

- Proven ability to develop and validate technical specifications and programs for safety and efficacy analysis datasets.
- Strong problem-solving skills and ability to communicate processes with management and team members.
- Expertise in SAS/Base, SAS/Macro, SAS/STAT, with knowledge of SAS/Graph and SAS/SQL.
- Familiarity with SDTM and ADaM, Good Clinical Practices, Good Programming Practices, and relevant regulatory standards.

**About Alexion Canada:**

Since operations began in Canada in 2009, Alexion has focused on bringing innovative medicines to Canadians living with rare diseases. With over 200 employees, our Canadian team includes a global research and development hub and dedicated professionals ensuring treatments reach those in need.

**Work Environment:**

We provide a flexible in-person working environment, encouraging collaboration and dynamic teamwork while respecting individual flexibility.

**Inclusivity Statement:**

Alexion embraces diversity and equality of opportunity, committed to building an inclusive and diverse team. We welcome applications from all qualified candidates, comply with non-discrimination laws, and provide accommodations for individuals with disabilities during the recruitment process.

To apply, please submit your application.