Principal Statistical Programmer

Responsibilities

• Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.
• Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.
• Following specifications, develops algorithms and writes programs to create datasets.
• Produces data listings, summary tables and graphs using SAS software.
• Independently check 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.
• Interact 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 Advance 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.