KH
Principal Statistical Programmer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Staff / Principal
- 9 months ago
- SAS
- GCP
- ICH
9 months ago
- 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.
- 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.
Principal Statistical Programmer · Katalyst Healthcares & Life Sciences