Senior Statistical Programmer Consultant – Oncology CDISC Expert

Socket.dev; United States; On-site; USD 110,000 - 175,000; Full time

Job summary

ClinChoice is seeking a Senior Statistical Programmer Consultant to join one of our client projects in a client-facing capacity. The role requires leadership in programming tasks, deep CDISC experience, and the ability to work with cross-functional teams in a global CRO setting.

You will collaborate with statisticians, data managers, and study teams to deliver high-quality programming deliverables while adhering to ICH/GCP standards and regulatory requirements.

Qualifications

• Bachelor’s degree in CS, statistics, or related disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree 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.

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.

Skills

ICH/GCP knowledge

Clinical drug development

Strong communication

Stakeholder influence

Oncology TA experience

Education

Bachelor's degree in CS, statistics, or related disciplines

Master's degree in CS, statistics or related disciplines

Job description

ClinChoice is seeking a Senior Statistical Programmer Consultant to join one of our client projects in a client-facing capacity. The role requires leadership in programming tasks, deep CDISC experience, and the ability to work with cross-functional teams in a global CRO setting.

You will collaborate with statisticians, data managers, and study teams to deliver high-quality programming deliverables while adhering to ICH/GCP standards and regulatory requirements.