Executive Director, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic and operational leadership in statistical programming for designated indications and development programs.

• Collaborate with biostatisticians and cross-functional teams to assess statistical analysis plans and create programming specifications for data and analysis.

• Ensure thorough, auditable, and inspection-ready programming documentation for clinical trial analyses and regulatory submissions.

• Oversee the creation, governance, documentation, and upkeep of reusable programming code, standards, templates, and best practices.

• Work alongside IT and functional leadership to define and sustain the statistical computing infrastructure, including the SAS server environment and related tools.

• Provide senior-level expertise in statistical programming and biometrics leadership for selected projects and cross-functional initiatives.

• Collaborate on the development of CRF/EDC and ensure quality data collection for assigned clinical trials.

• Manage biometrics vendors and external programming partners, ensuring timely delivery of high-quality outputs, issue resolution, and accountability.

• Conduct or oversee quality reviews of outsourced statistical deliverables, including in-house double programming or quality control as required.

• Lead or contribute to standards at the function level, including SOPs, work instructions, templates, and initiatives for continuous improvement.

• Stay updated on industry advancements in biostatistics, statistical programming, regulatory standards, automation, and data specifications.

• Develop programming strategies, set resource priorities, establish quality expectations, and create risk mitigation plans, communicating decisions and escalations to senior stakeholders.

• Perform additional duties as assigned.

• Work primarily in sedentary conditions, with common office or administrative environmental exposure.

⛳️ Requirements

• A./B.S. degree in statistics, computer science, or another quantitative science discipline is required.

• 17+ years of relevant experience in statistical programming, biometrics, or clinical development, including significant leadership roles in clinical development and regulatory submissions.

• Proven experience in leading statistical programming strategies and execution for regulatory submissions, including BLA/IND or equivalent submissions to global health authorities.

• 8+ years of management experience, including scaling up an in-house programming team.

• Advanced SAS programming skills, encompassing SAS/BASE, SAS Macros, SAS/STAT, and ODS.

• Proficiency in Microsoft Office applications, such as Word, Excel, and PowerPoint.

• Strong understanding of clinical trial standards, including CDISC, SDTM, ADaM, CDASH, MedDRA, and WHODrug.

• Knowledge of relevant GCP, FDA, CHMP, ICH, and HIPAA regulations.

• Travel requirement is less than 5%.

• Advanced degree preferred, or equivalent experience.

• Experience in ophthalmology and/or biologic/gene therapy is a plus.

• Proficiency in SAS/SQL, SAS/GRAPH, SAS/ACCESS, R, Excel/PowerPoint Chart features, P21 checks, and experience across clinical phases I–IV is desirable or a plus.

• Strong skills in organization, prioritization, time management, attention to detail, communication, analytical thinking, strategic planning, interpersonal relations, vendor management, people leadership, and project management.

• Ability to identify risks and facilitate decision-making, escalation, and resolution.

• Sedentary work with repetitive wrist, hand, finger, typing, and speaking activities.

🏝️ Benefits

• Equal employment opportunities without regard to protected characteristics.

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.