ClinChoice Benefits Overview

Leads statistical programming for clinical trials, developing and reviewing SAS programs, datasets, tables, listings, and figures. Supports SDTM/ADaM standards and regulatory submissions, reviews specifications and outputs, manages deliverables and timelines, collaborates with clinical teams, and provides technical guidance and mentorship to statistical programmers. Requires strong knowledge of clinical development, CDISC, ICH, Good Clinical Practices, and regulatory requirements.

Supports regulatory ancillary and sample requirements across assigned markets for international product approval submissions. Manages requests, timelines, client systems, and cross-functional communication in a matrix environment, escalating risks as needed. Requires regulatory experience, pharmaceutical organizational familiarity, strong communication, technical aptitude, quality focus, and advanced Microsoft Office skills.

Supports international regulatory submissions by managing market-specific ancillary and sample requirements, tracking requests against timelines, maintaining client systems, coordinating across matrixed functions, and escalating risks. Requires regulatory experience, pharmaceutical organizational familiarity, strong communication, quality focus, technical aptitude, leadership skills, and advanced Microsoft Office proficiency. This is a 12-month contract with possible extension and is remote.