Associate Director Statistical Programming

Associate Director, Statistical Programming

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.

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.  

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

Qualifications:

• BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
• 7+ years statistical programming experience in the CRO or Pharmaceutical Industry.
• 4+ years people and / or 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.
• Relational Databases.
• Good Clinical Practices.
• Good Programming Practices.
• 21CFR Part 11 Standards.
• Integrated Summary Safety/Efficacy Analyses.
• Creating all files necessary to support an electronic submission in the eCTD format.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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.