Associate Director - Statistical Programming

Job Title: Associate Director, Statistical Programming

Introduction to role

The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will 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, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables.

Accountabilities

- 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.
- Ensure 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.
- 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 to ensure that department standards are implemented in all studies.
- Manage adherence to all company policies, SOPs, and other controlled documents; 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.

Essential Skills/Experience

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

Desirable Skills/Experience

- BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
- Competencies:
  - Accountability
  - Collaboration
  - Decision Quality
  - Drive for Results
  - Perseverance
  - Problem Solving
  - Informing
  - Peer Relationships
  - Time Management
  - Building Effective Teams
  - Managing Through Systems

At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma leader. We foster an inclusive culture where innovation thrives, empowering our employees to grow both personally and professionally. Join us to be part of a team that is dedicated to transforming lives through groundbreaking science and compassionate care.

Ready to make an impact? Apply now!

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 authorisation and employment eligibility verification requirements.