Associate Director, Statistical Programming

Associate Director of Statistical Programming

Responsibilities
- Lead study/project statistical programming activities as lead programmer.
- Design and develop programming specifications and SAS programs to produce and validate CDISC-compliant datasets for regulatory submissions.
- Produce and validate regulatory submission tables, figures, and listings; support timely, high-quality ad-hoc exploratory analysis.
- Design, develop, implement, and maintain statistical programming automation and reporting tools for multiple projects.
- Provide project management and technical guidance; mentor junior programmers in standards, practices, and project management.
- Represent programming in cross-functional teams (biostatistics, clinical operations, data management, regulatory operations) to define deliverables, timelines, and alignment.
- Partner with IT to develop and maintain programming environments for secure, efficient analysis and reporting.

Qualifications
- Advanced degree (M.S. or Ph.D.) strongly preferred.
- 8+ years pharmaceutical/biotech and/or CRO experience.

Preferred Skills/Requirements
- Expert SAS programming (BASE SAS, SAS/STAT, SAS/GRAPH, SAS macros).
- Extensive CDISC SDTM/ADaM knowledge; strong ADaM specification writing and hands-on clinical trial reporting; experience with electronic FDA submissions.
- Proficiency in R and/or Python; ability to quickly learn new languages.
- Strong GCP/ICH guideline knowledge.
- Strong interpersonal, organizational, multitasking, attention to detail, and problem-solving skills.
- Good project management and CRO oversight; excellent written/oral communication.
- Neuroscience experience and SAS LSAF experience are pluses.

Compensation/Benefits (as stated)
- Annual base salary: $184,071–$198,796; eligible for annual performance pay bonus; competitive benefits package.