Associate Director, Statistical Programming

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

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

Preferred:
- Expert in SAS programming (BASE SAS, SAS/STAT, SAS/GRAPH, SAS macros).
- Extensive CDISC SDTM/ADaM knowledge; strong hands-on ADaM specification and clinical trial reporting experience; experience with electronic FDA submission.
- Proficiency in R and/or Python; ability to learn new languages quickly.
- Strong GCP/ICH guideline knowledge.
- Strong interpersonal, organizational, multi-tasking, attention to detail, and problem-solving skills.
- Project management/CRO oversight skills; excellent written and oral communication.
- Creative, independent thinking; neuroscience experience and SAS LSAF experience are a plus.

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