ClinChoice is seeking a Principal Statistical Programmer Consultant to join their client's Immunotherapy team. This role offers the unique opportunity to work directly with a single sponsor while benefiting from the stability and career growth potential of a global CRO.He/She will be responsible for leading and supporting programming activities, working independently to implement and drive programming for ongoing clinical studies, and fulfilling requests for study reports and regulatory submissions.Role involves:
Developing Tables, Figures, and Listings (TFLs) from existing SAS programs or from scratch.
Independently programming and reviewing reports and outputs.
Customizing outputs and graphics based on target audience specifications.
Supporting programming deliveries for clinical studies or projects.
Contributing to the development of best practices for quality improvement.
Ensuring compliance with standards and automation usage.
Planning and supporting team activities and tasks.
Communicating and escalating risks within assigned studies and projects.
Requirements:
Bachelor’s degree in computer science, statistics, or related field with 10+ years of clinical programming (CDISC) experience; or Master’s degree with 8+ years of experience.
Immunology TA experience is required.
ISS & ISE experience is required.
Working knowledge of ICH and Good Clinical Practices.
Strong understanding of the clinical drug development process.
Strong communication and coordination skills.
Current knowledge of technical and regulatory requirements.
Ability to proactively manage concurrent activities within a project.
Role offers:
Opportunity to work directly with a single sponsor.
ClinChoice is a global provider of regulatory and scientific services, specializing in preparing and submitting compliant Material Safety Data Sheets (MSDS/SDS). The company supports multinational chemical manufacturing companies, offering hazard analysis, SDS authoring, and regulatory compliance expertise across US, EU, and other international markets. ClinChoice focuses on establishing structured processes for SDS preparation, and delivers comprehensive hazard assessments and SDS phrases based on global regulatory standards. They provide mentorship and review services.