Associate Director-Statistical Programming

Job Title: Associate Director Statistical Programming
Introduction to role Are you ready to lead and innovate in the world of statistical programming? As the Associate Director of Statistical Programming, you will oversee programming activities for multiple clinical studies, ensuring compliance with SOPs and delivering quality results on time With your extensive SAS expertise and understanding of CDISC SDTM and ADaM standards, you'll support Biostatistics in generating analysis data listings, tables, and figures Your strong people management skills will be crucial as you provide direct line management to statistical programmers and manage external partners Are you prepared to make a significant impact? Accountabilities Serve as the Lead Programmer and Manager of statistical programming efforts Develop and vali technical programming specifications for analysis datasets using Alexion or ADaM standards Independently develop and vali programs for analysis datasets based on specifications Develop and vali technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs Ensure study documentation is maintained to audit standards Support the Clinical and Statistical Programming Director in managing the Statistical Programming team Participate in reviewing processes to ensure compliance and up Create/review programming plans and ensure resource allocation Act as the primary department contact for implementing standards in studies Manage adherence to company policies, SOPs, and departmental standards Collaborate with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions 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 vali 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 include Accountability, Collaboration, Decision Quality, Drive for