Associate Director, Statistical Programming

Role

Associate Director, Statistical Programming supporting clinical development in rare disease therapies, primarily remote from San Diego.

Responsibilities

• develop programming standards, oversee analysis datasets, tables, figures, listings, and submissions;
• lead projects, manage external vendors, review/produce SDTM, ADaM, and Define.xml documentation;
• ensure quality and timely delivery of programming outputs for regulatory submissions including INDs, NDAs, and safety reports.

Requirements

• Bachelor's in Statistics, Computer Science, or related field;
• 8+ years in clinical SAS programming, with 3-5 years in leadership roles;
• experience with SDTM, ADaM, CDISC standards, and submission support;
• strong SAS, UNIX, Windows, and MS Office skills;
• knowledge of drug development processes and regulatory guidelines (ICH, GCP, FDA, CHMP).

Preferred

• experience with R, vendor management, and cross-functional collaboration.

HighValue

supporting global clinical trials in rare diseases, primarily Phase I-III; emphasis on regulatory compliance, data standards, and submission readiness; work involves cross-functional coordination and vendor oversight.

WorkSetup

remote, based in San Diego, with face-to-face requirements; no specific travel mentioned.