Director, Statistical Programming

Responsibilities

• Manage a group of statistical programmers to provide programming support for assigned projects from datasets creation to data analysis
• Serve as lead statistical programmer for regulatory filing teams to support integrated data analyses
• Deliver high quality SDTM and ADaM datasets meeting CDISC standards
• Deliver high quality integrated databases to support safety and efficacy analyses
• Produce high quality DEFINE packages for SDTM and ADaM
• Manage vendor deliverables regarding quality, timeline, and budget in collaboration with biostatisticians
• Perform statistical data analysis and independent validation using SAS programs
• Participate in developing SOPs and processes for statistical programming activities

Requirements

• Master's Degree in Biostatistics, Statistics, Computer Science, or a relevant field
• At least 15 years of experience in statistical programming for clinical trial data in pharma, biotech, or CRO environments
• Proven experience building and leading statistical programming groups
• Deep understanding of data standards and creating DEFINE packages for regulatory filing
• Proficiency in SAS, including complex data steps, macro languages, and analysis procedures (PROC Freq, REPORT, GLM, MIXED)
• Extensive experience in statistical vendor management
• Strong organizational, project, and resource management skills

Preferred Qualifications

• Experience providing statistical programming support for CNS clinical trials
• Experience providing statistical programming support for regulatory filing

Benefits

• 100% paid health benefits including Medical, Dental, and Vision for employees and dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders.