Senior Statistical Programmer - Katalyst Healthcares & Life Sciences
Basking Ridge, NJ 07920
About the Job
Responsibilities:
- Perform data manipulation, analysis and reporting of primarily clinical trial data
- Program and generate tables, listings, and graphs (TLGs)
- Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
- Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
- Participate in study team meetings and address issues that may affect statistical programming.
- Validate and document SAS programs and output.
- Create SDTM and ADaM Datasets and related documentation.
- Fulfill ad-hoc programming requests.
- Other duties as needed.
- 15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companies.
- Strong submissions experience (BLA, NDA/sNDA and EMA) and end to end programming experience.
- Knowledge and experience working with CDISC Standards (MUST have expertise in both SDTM/ADaM, developing specifications for both).
- Demonstrated ability performing all levels of programming activities for a clinical project.
- Experience working in the Cardiovascular or Neuromuscular areas is a plus.
Source : Katalyst Healthcares & Life Sciences
