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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