This is a fully remote position, open to applicants in California.

📋 Description

• Assist in Peripheral Vascular clinical research initiatives

• Offer statistical programming and analytical support for clinical research studies, publications, and regulatory submissions

• Oversee the creation, validation, and timely provision of statistical programming outputs, which include tables, figures, listings, CDISC ADaM datasets, and data issue reports

• Design and execute CDISC ADaM specifications and programming solutions utilizing SAS and R, encompassing R functions and SAS macros

• Examine study protocols, Statistical Analysis Plans, as well as tables, figures, and listings shells

• Collaborate with statisticians, clinicians, and cross-functional study teams to develop and document clinical endpoint algorithms

• Perform exploratory statistical analyses and verify results for abstracts, presentations, manuscripts, publications, and regulatory submissions

• Create programs to gather and assess external study data for consistency and quality issues

• Manage programming projects, common code, study data structures, project trackers, and documentation while juggling multiple priorities

• Evaluate programming assignments, guide junior programmers, and suggest process enhancements

⛳️ Requirements

• Bachelor’s degree in Statistics, Mathematics, or a related discipline

• At least 2 years of experience in clinical statistical programming supporting clinical research in pharmaceutical, biotechnology, medical device, CRO, or similar regulated clinical environments

• Proficiency in SAS and/or R

• Familiarity with clinical programming domains such as CDISC ADaM standards, electronic data capture (EDC) data, or clinical data visualization

• Preferred: Master’s degree in Statistics, Mathematics, or related fields

• Preferred: Experience in programming for medical device clinical trials