Associate Director

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 - 10 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 Date Posted 06-Oct-2025 Closing Date 12-Oct-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy including childbirth breastfeeding or related medical conditions parental status including adoption or surrogacy military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law Alexion provides reasonable accommodations to meet the needs of candidates and employees To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in E-Verify