[Remote] Principal Statistical Programmer/Analyst Consultant (Cardiovascular, Renal)
Note: The job is a remote job and is open 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 Principal Statistical Programmer Consultant to reputed company and support programming efforts for clinical studies, ensuring high-quality deliverables and adherence to project timelines.
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 quality 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 8 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
Company Overview
Company H1B Sponsorship