Company:
Katalyst Healthcares & Life Sciences
Location: South Plainfield
Closing Date: 18/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
Programs independently with high efficiency and quality.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
Ensures compliance with standards and automation usage.
Plans and support team activities and tasks.
Communicates and escalates risks within the assigned studies and/or projects.
Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.
Requirements:
Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 yrs. of clinical programming (CDISC) experience; (or) Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
Need to have Oncology/Hematology TA experience.
Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical and regulatory requirements relevant for the role.
Ability to proactively manage concurrent activities within a project.
Proficient ability to influence relevant stakeholders on programming-related.
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
Programs independently with high efficiency and quality.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
Ensures compliance with standards and automation usage.
Plans and support team activities and tasks.
Communicates and escalates risks within the assigned studies and/or projects.
Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.
Requirements:
Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 yrs. of clinical programming (CDISC) experience; (or) Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
Need to have Oncology/Hematology TA experience.
Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical and regulatory requirements relevant for the role.
Ability to proactively manage concurrent activities within a project.
Proficient ability to influence relevant stakeholders on programming-related.
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