Associate Director / Director, Statistical Programming

MeiraGTx • New York, NY

1h • Remote

About The Position

The Associate Director / Director, Statistical Programming will provide technical and operational leadership for statistical programming across clinical studies and development programs. The role is accountable for the quality, accuracy, timeliness, traceability, and regulatory readiness of programming deliverables, including SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, exploratory analyses, and responses to regulatory questions.

This is a hands-on leadership role in a growing biotechnology environment. The successful candidate will combine strong programming expertise with strategic oversight of CROs and contractors, effective cross-functional partnership, and a practical focus on scalable standards, automation, and fit-for-purpose processes.

The position is remote, with preference for candidates in the U.S. Eastern time zone. Travel may be required up to 10–15% based on business needs. The role may require flexibility during database locks, major submission milestones, or urgent regulatory responses.

MeiraGTx is a clinical-stage gene therapy company developing treatments for serious diseases. Its clinical programs include ocular indications, a salivary gland condition, and Parkinson’s disease. The company has headquarters in New York and London and capabilities in viral vector design, optimization, and gene therapy manufacturing.

Requirements

• 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.
• 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 resolving validation findings in a documented, risk-based manner.
• 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 ability to influence effectively in a cross-functional matrix.

Nice To Haves

• 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.

Responsibilities

• Provide technical and operational leadership for statistical programming across clinical studies and development programs.
• Ensure the quality, accuracy, timeliness, traceability, and regulatory readiness of programming deliverables.
• Produce and oversee SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, and exploratory analyses.
• Prepare or support responses to regulatory questions.
• Provide strategic oversight of CROs and contractors.
• Partner effectively with cross-functional teams.
• Support scalable standards, automation, and fit-for-purpose programming processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Director