Principal Statistical Programmer

Responsibilities

• writes specifications for SDTM datasets following the Study Data Tabulation Model (SDTM) Implementation Guide
• writes specifications for analysis datasets following the Statistical Analysis Data Model (ADaM) Implementation Guide
• develops algorithms and writes programs to create datasets
• produces data listings, summary tables and graphs using SAS software
• independently checks data listings, summary tables and graphs
• imports and exports SAS data
• assists data management group in performing data edit checks
• understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements
• plays an active role in taking project solutions and generalizing them for the Biostatistics group
• interacts with the project statistician and guides other programmers participating on a project team
• experience with pooled analysis, regulatory agencies requirements and e-submission experience

Requirements

• Minimum of 10+ years of statistical programming experience in the life science industry and relevant bachelor's degree
• Must have recent NDA submissions experience
• ISS/Client safety & efficacy experience is required
• Experience creating define.xml and experience with Pinnacle 21 and specifications
• SAS Certified Base and/or Advanced Programmer experience is preferred
• Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS
• Experience with SDTM and ADaM industry data standards
• Good communication skills and attention to detail are crucial
• Proven ability to handle multiple tasks
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information