Principal Statistical Programmer

The Associate Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. They must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles.  They will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use hitheirtrong people management skills and supervisory skills to provide direct line management to the statistical programmers,  identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices.

You will be responsible for:

Serve as the Lead Programmer and Manager of the statistical programming efforts. This may include additional responsibilities including, but not limited to:

• 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.

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

• Ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.

• Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Responsibilities will include, but are not limited to:

• Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.

• Create and/or review programming plans, and ensure appropriate resource allocation and prioritization.

• Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.

• Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards

Assume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans as required.

Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.

You will need to have:

• 7+ years statistical programming experience in the CRO or Pharmaceutical Industry.

• 2-5 years people and project management experience in the CRO or Pharmaceutical Industry.

• Experience with CDISC SDTM and ADaM models and transforming raw data into those standards.

• Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion.

• Strong verbal and written communication skills - ability to clearly and effectively present information.

• An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance.

• Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.

• Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs.

• Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.

• Advanced experience with: Constructing technical programming specifications

• 21CFR Part 11 Standards.

• Integrated Summary Safety/Efficacy Analyses.

• Creating all files necessary to support an electronic submission in the eCTD format.

We would prefer for you to have:

• BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.

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 E-Mail schreiben.