Associate Director, Statistical Programming

Overview In this role you will lead statistical programming efforts to deliver CDISC-compliant datasets and outputs for regulatory submissions, combining technical programming with project leadership. You will mentor staff, drive automation, and collaborate across biostatistics, data management, and regulatory operations to ensure high-quality, timely deliverables. This position supports Alkermes’ neuroscience portfolio and regulatory goals in a global setting. You will shape scripting standards and innovative tools to improve efficiency and data security. Compensation / Benefitsbase salary with annual performance bonuscompetitive benefits packageopportunity to influence neuroscience programsequal employment opportunitywork with global teamsprofessional development opportunities ResponsibilitiesLead study- or project-level statistical programming activities and coordinate related tasksDesign and develop SAS programs for CDISC-compliant datasets and regulatory outputsProduce and validate submission-ready tables, figures, and listings; support exploratory analysesDevelop and maintain automation tools for programming workflows across projectsProvide project management and technical guidance; mentor junior staff on standards and practicesRepresent statistical programming in cross-functional teams and align deliverables with stakeholdersCollaborate with IT to maintain secure, efficient programming environments Key requirementsAdvanced SAS programming expertise (BASE SAS, SAS/STAT, SAS/GRAPH, SAS MACROS)Extensive CDISC SDTM and ADaM experience with ADaM specificationsStrong hands-on SAS programming for clinical trial reporting and regulatory submissionsExperience with electronic submissions to FDAProficiency in R and/or Python; ability to learn new languages quicklyKnowledge of GCP/ICH guidelines for clinical trials8+ years in pharma/biotech or CRO settingsExcellent communication, organizational, and multitasking skillsAbility to work independently in a dynamic environmentNeuroscience experience a plusSAS LSAF experience a plusInterpersonal skillsOrganizational skillsMultitaskingSAS programming (BASE SAS, SAS/STAT, SAS/GRAPH, SAS MACROS)CDISC SDTM/ADaMRegulatory submission experience