Associate Director, SAS Programming

Role overview

Lead statistical programming for an assigned clinical development compound, with responsibility for the quality, consistency, timelines, and submission readiness of programming deliverables across studies. The role combines hands-on development and validation with strategy, resource planning, vendor oversight, and improvements to programming standards and practices.

Responsibilities - Set compound-level programming strategy, including standards, integrated dataset design, and validation methods. - Coordinate lead programmers and plan internal and external resources against study and program milestones. - Develop and validate SDTM, ADaM, and tables, listings, and figures for priority milestones, analyses, and regulatory submissions. - Provide programming input to analysis plans, mock shells, case report forms, edit checks, and data transfer specifications. - Review study specifications for consistency and design integrated datasets for pooled analyses and cross-study comparisons. - Oversee CRO and FSP programming work, submission documentation, quality expectations, and timelines; provide rapid analyses for leadership and regulatory requests.

Requirements - The available source emphasizes leadership of compound-level statistical programming and delivery across multiple studies. - Ability to develop and validate clinical programming outputs and integrated datasets. - Experience setting validation approaches and maintaining consistency with analysis plans and programming standards. - Ability to coordinate internal programmers and external vendors against quality and schedule expectations. - Clear communication of status, risks, issues, and decisions to technical and non-technical partners. - Working knowledge of applicable clinical research and regulatory requirements is needed to deliver compliant submission materials and support audits or inspections.

Benefits and work setup - U.S.-based benefits include medical, dental, and vision coverage; employer-matched 401(k); equity and employee stock purchase opportunities; paid vacation, holidays, sick time, and parental leave; tuition assistance; and employer-paid life, disability, travel, and employee assistance coverage.