Principal Statistical Programmer

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 Tables, Listings, and Figures (“TLFs”) for analysis of efficacy data.  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 serve as a Programming Lead and represent Clinical and Statistical Programming in meetings with internal and external clients and cross-functional project teams.  The Principal Statistical Programmer will act as a mentor to all other Statistical Programmers. They must demonstrate, at a minimum, an expert ability to comprehensively integrate statistical concepts with SAS Programming in the most efficient and effective manner. 

You will be responsible for:

• 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 technical programming specifications for protocol specific efficacy tables, listings, figures/graphs based on Protocol SAP.

• Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications.

• Supervise/manage external vendors and contract programmers.

• Oversee 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, when necessary, to ensure that department standards are implemented in all studies.

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

You will need to have:

• Bachelor’s Degree (Minimum) or Master’s Degree (Preferred) in Biostatistics, Statistics or another related discipline

• Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.

• Proven track record 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

• Expertise in using SAS/Base, SAS/Macro, SAS/STAT.

• Knowledge of SAS/Graph, and SAS/SQL 

• Knowledge of:

  • SDTM and ADaM

  • Relational Databases.

  • Good Clinical Practices.

  • Good Programming Practices.

  • 21CFR Part 11 Standards.

  • Integrated Summary Safety/Efficacy Analyses.

  • Safety data and Coding Dictionaries (MedDRA and WHODD).

  • ICH eCTD format.

Alexion Canada

Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.

Our Canadian team

We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.

How we work
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 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.

Alexion 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. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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