Bachelor’s degree in computer science, statistics, or related scientific disciplines with 6 years of clinical programming (CDISC) experience; Master’s degree with 8 years of experience.
Oncology/Hematology TA experience is required.
Experience with ISS & ISE is required.
Working knowledge of ICH, Good Clinical Practices, clinical research, clinical trial process, and related regulatory requirements.
Good understanding of the clinical drug development process.
Strong communication and coordination skills.
Current knowledge of technical and regulatory requirements for the role.
Ability to manage concurrent activities proactively.
Responsibilities:
Lead and support all programming activities per project strategies.
Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs and from scratch for new outputs.
Customize outputs and graphics according to delivery specifications.
Support Programming deliveries of clinical studies.
Program independently with high efficiency and quality.
Contribute to best practices for quality and efficiency.
Ensure compliance with standards and usage of automation.
Plan and support team activities and tasks.
Communicate and escalate risks within assigned studies.