Provide technical leadership for statistical programming activities for a given clinical development program.
Accountable for the accuracy, quality, and timeliness of programming deliverables for clinical trial reporting, integrated safety/efficacy analyses, and global regulatory submissions.
Drive the development and maintenance of programming standards and tools, ensuring compliance with CDISC standards, ICH GCP, and applicable regulatory requirements.
Collaborate closely with cross‑functional teams and external vendors.

Requirements

Master’s or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or related field (BS with significant experience considered).
7+ years of statistical programming experience in pharmaceutical, biotechnology industry w/ Bachelors. 4+ years w/ Masters. 3+ years w/ PhD
Expert proficiency in SAS (Base, Macro, Stat, Graph, ODS); working knowledge of R or Python preferred.
Deep knowledge of CDISC SDTM/ADaM standards, metadata, and regulatory submission requirements.
Experience with Pinnacle 21 and preparation of reviewer’s guides.
Strong understanding of clinical trial design, data collection, and reporting processes.
Experience in Gene Therapy
Experience in ophthalmology preferred
Excellent communication, problem‑solving, and project management skills.
Ability to manage multiple priorities in a fast‑paced, matrixed environment.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

statistical programmingSASRPythonCDISC SDTMCDISC ADaMdata collectionclinical trial designregulatory submissionprogramming standards

Soft Skills

communicationproblem-solvingproject managementcollaborationleadershiporganizational skillstime managementadaptabilityattention to detailcritical thinking