Associate Director / Director, Statistical Programming

Required Qualifications

• Bachelor’s or advanced degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences, or a related quantitative discipline.
• At least 10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry, including demonstrated study or program leadership, BLA/NDA/MAA submission experience, vendor oversight, and functional or people leadership.
• Advanced SAS programming skills, including SAS/BASE, SAS Macro, SAS SQL, ODS, and programming for clinical data analysis and reporting.
• Advanced knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and associated implementation guidance.
• Demonstrated experience producing and overseeing programming deliverables for clinical study reports and regulatory submissions.
• Working knowledge of the clinical drug-development process, clinical trial methodology, statistical concepts, GCP, ICH guidance, and electronic submission expectations.
• Experience with data and submission validation tools such as Pinnacle 21 and with resolving validation findings in a documented, risk-based manner.
• Proven ability to manage multiple priorities, anticipate risks, negotiate realistic timelines, and deliver high-quality work in a fast-paced environment.
• Excellent written and verbal communication skills, sound judgment, attention to detail, and the ability to influence effectively in a cross-functional matrix.

Preferred Qualifications

• Hands-on experience with global regulatory submissions, including NDA, BLA, MAA, or equivalent submissions, integrated summaries, information requests, inspections, and post-submission analyses.
• Experience in rare disease, gene therapy, ophthalmology, or another complex clinical-development setting.
• Experience with R and relevant clinical-development ecosystems; familiarity with Python, XML, Git, or metadata-driven reporting is an advantage.
• Experience building or governing reusable programming infrastructure, macro libraries, automated QC frameworks, and reproducible reporting workflows.
• Experience authoring or implementing SOPs, work instructions, programming standards, and vendor governance processes.
• Familiarity with validated cloud or collaborative programming environments and responsible use of AI-assisted programming tools.

Core Competencies

• Clinical programming and regulatory submission leadership.
• Quality, compliance, and inspection readiness.
• Strategic planning and risk management.
• CRO and vendor oversight.
• Cross-functional influence and communication.
• Technical problem-solving and innovation.

Working Conditions

• Work arrangement: Remote, US eastern standard time zone preferred.
• Travel: up to 10-15%, based on business needs.
• The role may require flexibility during database locks, major submission milestones, or urgent regulatory responses.