Director, Statistical Programming
This is what you will do:
The Director of Statistical Programming will be primarily responsible for leading all aspects of statistical programming activities for multiple clinical studies within multiple Therapeutic Areas, 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 their strong people management skills and supervisory skills to provide direct line management to statistical programmers and external partners, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices. They should be able to identify project resource requirement needs and manage large external provider contract budgets. They will be responsible for the direct-line management of the statistical programmers through Associate Director level staff.
You will be responsible for:
Serve as the Lead Programmer and Manager of the statistical programming efforts.
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.
Provide secondary reviews of Statistical Programming deliverables.
Directly support the Statistical Programming Sr. 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.
Plan and manage department budget. Forecast quarter, annual, and 3-5 year budget. Participate in strategic development meetings across departments.
Evaluate, develop, revise, implement and ensure compliance to functional guidelines, policies, and SOPs.
Collaborate across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications and computing environment support.
Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.
Collaborate closely with Preferred Vendor management in terms of governance, recruiting needs, contract development and signature, and any other partnership requirement that may arise.
You will need to have:
A minimum of 10 years of Biostatistics/SAS programming experience, including at least 3 years managing direct reports.
Advanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.
Thorough understanding of relational databases and their correlation to submission ready database structure.
Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation
Significant experience in a leadership capacity with a focus on identifying, leading and advancing talent.
Experience working in a clinical development organization with a heavy emphasis on support of multiple, ongoing projects
Thorough understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.
Thorough understanding of industry standards such as CDISC and 21CFR Part 11.
Strong ability to solve problems, recommend process improvements, and execute on process improvements.
Ability to lead and influence teams
Excellent verbal and written communication skills in a global environment.
Proven ability to work with cross functional teams, specifically Data Management, Biostatistics, Epidemiology, Clinical Operations, and Pharmacovigilance to initiate, lead and execute new initiatives and process improvements.
Recognize behaviors that align with our values critical to the success of our employees, mission, and business objectives.
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 AZCHumanResources@astrazeneca.com.
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.
