Senior Statistical Programmer Analyst/Consultant

ClinChoice

United Kingdom

Main Job Tasks and Responsibilities:

The Senior Statistical Programmer Analyst/Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks.

Key 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.

Education and Experience:

Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience;
Need to have Oncology 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 items.

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