Clinical SAS Programmer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- 8 years hands on statistical programming experience in the pharma/biotech industry
- Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, and SAS Macros, preferrable experience using R.
- Desire to understand the disease area, protocol, SAP, and study related documents.
- Good knowledge of clinical trial design, and statistical terminology.
- Strong knowledge of CDISC SDTM and ADaM data models.
- Demonstrated proficiency in developing dataset specifications, and using SAS/R to produce SDTM datasets, ADaM datasets, and TFLs.
- Thorough understanding of clinical data structures, and data exchange with multiple data formats.
- Expertise in performing validation of datasets, and TFLs using risk-based approach.
- Expertise in regulatory submissions, preparation of e-sub package.
- In-depth understanding of regulatory, industry, and technology standards and requirements.
- Exceptional organizational, communication and time management skills, with the ability to multi-task across projects.
- Demonstrated ability to work in a team environment with cross-functional teams.
- Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, and SAS Macros, preferrable experience using R.
- Strong knowledge of CDISC SDTM and ADaM data models.
- Demonstrated proficiency in developing dataset specifications, and using SAS/R to produce SDTM datasets, ADaM datasets, and TFLs.
- Expertise in regulatory Submissions.
Source : Katalyst Healthcares & Life Sciences
