Statistical Programmer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
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 with high quality.
- Represent the Clinical Programming function at cross-functional meetings.
- May support EDC development and visualization tools (PowerBI).
- Communicate with peers and senior management in support of study goals.
- Contribute to the team's continuous improvement efforts.
- Train and mentor junior staff.
- Additional study-specific activities.
- Minimum 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, Health Canada).
- Programming experience in R, SQL, JSON.
- Working experience with relational databases.
- Experience developing technical specifications for SDTM, ADS, or ADaM standards.
- General understanding of the clinical trial process and regulations that apply (GCP, GCDMP).
- Experience implementing CDISC standards is desirable.
Source : Katalyst Healthcares & Life Sciences
