Associate Director, Statistical Programming

This is what you will do :

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. He / She 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. He / She will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use strong people‑management skills to provide direct line management to the statistical programmers, identify training needs, optimize staff utilization, and employ the most efficient practices. The role will manage the day‑to‑day activities of our external partners in the delivery of program deliverables.

You will be responsible for :

• Serve as the Lead Programmer and Manager of the statistical programming efforts, including developing and validating 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, and figures / graphs.
• Independently develop and validate programs that generate protocol‑specific efficacy tables, listings, and figures / graphs using Alexion specifications.
• Ensure that the filing of study documentation is maintained to the required standard according to processes and is acceptable for audit.
• Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team, including reviewing processes to ensure continual compliance and update as necessary.
• Create and 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.
• 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 :

We would prefer for you to have :

Competencies

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

#J-18808-Ljbffr