Bachelor's Degree in relevant field (Data Science, Computer Science, etc.)
Proficient in SAS/R for generating and validating datasets
Must have experience with regulatory submissions (FDA)
Familiarity with SQL and JSON is a plus
Experience with relational databases and EDC systems (IBM Zelta)
Knowledge of CDISC standards is desirable
Strong communication skills, both oral and written
Analytical, creative, and innovative problem-solving abilities
Willingness to learn and adapt.
Responsibilities
Generate and validate TLFs per Statistical Analysis Plan and specifications.
Perform programming and documentation activities independently for assigned studies.
Adhere to SOPs and industry standards for compliance and traceability.
Assist in preparing and reviewing electronic regulatory submissions.
Ensure timely and high-quality completion of all deliverables.
Represent Clinical Programming in cross-functional meetings.
Support development of EDC and visualization tools like PowerBI.
Full Job 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.
nalytical skills, creativity and innovative approach to problem solving.
Propensity for continuous learning and experimentation.
Demonstrated initiative and problem-solving skills, critical thinking skills.
