About The Position
ClinChoice is seeking a Principal Statistical Programmer Consultant to work directly with one of its clients while employed within a global CRO. This client-facing, delivery-focused role operates under the leadership, oversight, and direction of a Programming team leader. The consultant leads and/or supports programming work for clinical studies or projects, delivering technical programming and information components. The position calls for strong technical skills, thorough industry knowledge, independent programming, and the ability to build a high-trust working relationship with client counterparts. The role supports programming deliverables for clinical studies and projects and implements statistical programming aspects of protocols and clinical development programs. It also contributes to programming best practices, quality, efficiency, and effectiveness, and ensures compliance with standards and use of automation. The consultant works proactively with study team members, including statisticians, lead programmers, data managers, and study leaders.
Requirements
- Bachelor’s degree in computer science, statistics, or a related scientific discipline and 5 years of clinical programming (CDISC) experience; alternatively, a master’s degree in computer science, statistics, or a related discipline and 6 years of clinical programming (CDISC) experience.
- Working knowledge of ICH and Good Clinical Practices, clinical research, the clinical trial process, and related regulatory requirements and terminology.
- Good understanding of the clinical drug development process.
- Strong communication and coordination skills.
- Current knowledge of technical and regulatory requirements relevant to the role.
- Ability to proactively manage concurrent activities within a project.
- Ability to influence relevant stakeholders on programming-related items.
- Ability to work independently and establish a high-trust environment with client counterparts.
Responsibilities
- Support programming deliverables for a clinical study or project.
- Implement statistical programming aspects of protocols and clinical development programs.
- Build quality into own deliverables and the quality of other programmers’ work.
- Program independently with high efficiency and quality.
- Write and/or implement specifications and oversee the completeness of relevant documentation.
- Contribute to best practices that improve quality, efficiency, and effectiveness within the function.
- Ensure compliance with standards and use of automation.
- Plan and support team activities and tasks.
- Communicate and escalate risks within assigned studies and/or projects.
- Work proactively with study team members, including statisticians, lead programmers, data managers, and study leaders.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
