Company:
Katalyst Healthcares & Life Sciences
Location: South Plainfield
Closing Date: 16/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
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.
Requirements:
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.
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.
Requirements:
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.
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