Principal Statistical Programmer/Analyst Consultant (Cardiovascular, Renal)

ClinChoice

14h

About The Position

This role is for a Principal Statistical Programmer Consultant who will work directly for a single sponsor while having the security and additional career opportunities of a global CRO. The position involves leading and/or supporting programming efforts to deliver technical programming and information components of a project. It requires high technical skills and thorough industry knowledge to independently perform programming tasks. The consultant will work under the leadership, oversight, and direction of a Programming team leader.

Requirements

• Strong SAS programming experience within 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 related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; OR Master’s degree in CS, statistics or related 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 related regulatory requirements and terminology.

Nice To Haves

• Experience supporting regulatory submissions is preferred.

Responsibilities

• Lead and/or support aspects of the programming effort to deliver technical programming and information components of a project.
• Develop, validate, and maintain SAS 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal