Company:
Katalyst Healthcares & Life Sciences
Location: Princeton
Closing Date: 19/11/2024
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 of high quality.
Represent the Clinical Programming function at cross-functional meetings.
May support EDC development and visualization tools (PowerBI).
Requirements:
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.
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).
Requirements:
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.
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