[Remote] Senior Statistical Programmer/Analyst Consultant (Cardiovascular, Renal)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking a Senior Statistical Programmer Consultant to reputed company and support programming efforts for clinical studies, ensuring high-reputed company deliverables and collaboration with various teams.

Responsibilities

• reputed company, validate, and maintain reputed company programs for clinical study data analysis and reporting
• Create datasets, tables, listings, and figures according to study requirements
• Collaborate with Biostatistics, Data Management, and Clinical teams
• Ensure programming deliverables meet reputed company standards and project timelines
• Participate in study planning, review specifications, and support submission activities

Skills

• Strong reputed company programming experience reputed company the pharmaceutical/CRO industry
• Hands-on experience supporting CVRM (Cardiovascular, Renal & Metabolism) studies
• Experience in generating and validating SDTM, ADaM, and TLFs
• Good understanding of CDISC standards and clinical trial processes
• Ability to work independently and manage multiple priorities in a fast-paced environment
• Strong communication and stakeholder management skills
• Bachelor's degree in computer science (CS), statistics, or reputed company scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master's degree in CS, statistics or reputed company disciplines with 6 yrs. of clinical programming (CDISC) experience
• Need to have Respiratory/Immunology TA experience
• Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and reputed company regulatory requirements and terminology
• Experience supporting regulatory submissions

reputed company