Associate Director, Statistical Programming

Responsibilities:
- Function as lead programmer to coordinate study/project statistical programming activities.
- Design and develop programming specifications and SAS programs to produce and validate CDISC-compliant datasets for regulatory submission deliverables.
- 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/reporting tools to support multiple projects.
- Provide project management and technical guidance; mentor junior staff in programming practices, standards, and project management.
- Represent statistical programming in cross-functional teams; collaborate with biostatistics, clinical operations, data management, and regulatory operations to define deliverables and timelines.
- Work with IT to develop/maintain programming environments ensuring data security and efficient analysis/reporting.

Qualifications:
Basic Requirements
- Advanced degree strongly preferred (M.S. or Ph.D.) with strong analytical skills.
- Minimum 8+ years experience in pharmaceutical/biotech and/or CRO settings.

Preferred Requirements
- Expert SAS programming (BASE SAS, SAS/STAT, SAS/GRAPH, SAS macros).
- Extensive CDISC SDTM/ADaM knowledge; strong experience writing ADaM specifications; strong hands-on SAS for clinical trial reporting; experience with electronic FDA submission.
- R/Python proficiency preferred; ability to quickly learn new languages.
- Strong GCP/ICH knowledge.
- Strong interpersonal, organizational, multitasking, attention to detail, problem-solving, and project management/CRO oversight skills.
- Strong written/oral presentation and communication skills.
- Neuroscience experience and SAS LSAF experience are plus.

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