Associate Director, SAS Programming

acadiapharmaceuticals; États-Unis; À distance; USD 150 000 - 210 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision coverage

401(k) plan with employer match

Equity and employee stock purchase

Paid vacation and parental leave

Résumé du poste

Acadiapharmaceuticals in the United States is seeking a Lead Statistical Programmer to steer compound-level programming and ensure delivery across studies, combining hands-on development with strategic oversight.

You will manage resources and vendor relationships, drive SDTM/ADaM development, and deliver submission-ready analyses while upholding coding standards and regulatory compliance.

Qualifications

• Experience leading compound-level statistical programming across multiple studies.
• Ability to develop and validate clinical programming outputs and integrated datasets.
• Experience defining validation approaches and ensuring consistency with analysis plans.
• Ability to coordinate internal programmers and CROs against quality and timelines.
• Strong communication of status, risks and decisions to technical and non-technical partners.
• Working knowledge of regulatory requirements for submissions and audits.

Responsabilités

• Set compound-level programming strategy and validation methods.
• Coordinate lead programmers and allocate internal/external resources.
• Develop and validate SDTM, ADaM, and tables, listings, and figures for analyses and submissions.
• Contribute to analysis plans, mock shells, CRFs, edit checks, and data transfer specs.
• Review study specifications for consistency and design integrated datasets for pooled analyses.
• Oversee CRO and FSP programming, submission documents, quality expectations, and rapid analyses.

Connaissances

Leadership

Statistical programming

SDTM/ADaM

Regulatory submissions

Vendor coordination

Outils

SAS

R

Description du poste

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.