Principal Statistical Programmer Katalyst Healthcares & Life Sciences - 4.0 Hartford, CT Job Details Contract 1 day ago Qualifications FDA submissions Statistics

XML SAS SAS

language Bachelor's degree CDISC standards Regulatory submissions Data analysis software

Full Job Description 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.