Clinical Statistical Programmer - Katalyst Healthcares & Life Sciences
Princeton, NJ 08540
About the Job
Responsibilities:
- Generate and validate TLFs based on the Statistical Analysis Plan, TLF specifications, and industry best practices.
- With minimal oversight, perform all programming activities and documentation for assigned studies.
- Follow departmental Standard Operating Procedures (SOPs) and industry guidance to ensure traceability and regulatory compliance.
- Support the preparation and review of the electronic regulatory submission.
- Ensure that all deliverables are completed on time and of high quality.
- Represent the Clinical Programming function at cross-functional meetings.
- May support EDC development and visualization tools (PowerBI).
- Minimum 3-5 years in a clinical programming role.
- Bachelor's Degree (Data Science, Computer Science, Statistics, Bioinformatics, or related discipline).
- Independently develop SAS/R programs to generate and validate datasets according to the Statistical Analysis Plan, TLF specifications, and industry best practices.
- Experience generating outputs for regulatory submissions (FDA) MUST.
- Programming experience in SQL, JSON (Good to have).
- Working experience with relational databases. (EDC system, IBM (Zelta).
- Experience implementing CDISC standards is desirable.
- Knowledge of EDC development and visualization tools (PowerBI, Tableau) is an asset.
- Excellent Communications skills, both oral and written.
- Analytical skills, creativity and innovative approach to problem solving.
- Propensity for continuous learning and experimentation.
- Demonstrated initiative and problem-solving skills, critical thinking skills.
Source : Katalyst Healthcares & Life Sciences
