Associate Director, Statistical Programming

Role overview Lead statistical programming for assigned clinical trials across development, regulatory submission, and commercialization. The role combines study team collaboration, review of vendor and internal deliverables, independent quality checks, and analysis support for clinical data review and regulatory work.

Responsibilities - Serve as lead programmer for assigned trials and coordinate programming support with statisticians, data management, and other study partners. - Review trial and integrated data packages, including aCRFs, SDTM and ADaM datasets, validation reports, study data review guides, analysis guides, and Define XML, for quality and regulatory readiness. - Oversee vendor deliverables with the study biostatistician, monitoring quality and timelines. - Independently validate vendor and internal datasets and analytical outputs. - Partner with clinical data management on reports that support data review and cleaning. - Review case report forms and data transfer specifications; contribute to analysis plans, table, listing, and figure shells, and analyses for publications or regulatory responses.

Requirements - Master’s degree in biostatistics, statistics, computer science, or a related field, with at least 12 years of clinical trial statistical programming experience. - Strong knowledge of clinical data standards, Pinnacle 21 validation, and Define XML packages for regulatory submissions. - Proficiency in SAS, including complex data steps, macros, and procedures such as FREQ, REPORT, GLM, and MIXED. - Effective collaboration, organization, project management, communication, and attention to detail across multiple projects. - Ability to deliver work effectively in a work-from-home setting.

Nice to have - Experience with CNS trial data structure and analysis. - Experience supporting integrated data analysis for regulatory filings.

Benefits and work setup - Starting base salary range: $155,000–$195,000 USD. Additional compensation may include bonus and equity. - Benefits include paid medical, dental, and vision coverage for employees and dependents, a 401(k) with company match, flexible time off, and parental leave.