Principal Statistical Programmer
Principal Statistical Programmer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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 bachelors degree
- Must have recent NDA submissions experience.
- ISS/Client safety & efficacy experience is required.
- Experience creating 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.
Employment Type
Full-time
