Clinical Statistical Programmer

Clinical Programmer

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.