Job
Description
- 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
