Principal Programmer - Statistical Programming

Job Description

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 based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Oversee progress of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Bachelor s Degree (Minimum) or Master s Degree (Preferred) in Biostatistics, Statistics or another related discipline Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge of: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.