Associate Director / Director, Statistical Programming

MeiraGTx; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

MeiraGTx is seeking an Associate Director/Director, Statistical Programming to lead technical and operational aspects of statistical programming across clinical studies. You will ensure quality, regulatory readiness, and timely delivery of SDTM/ADaM data, tables, and define.xml, while guiding CROs and internal teams.

The role blends hands-on programming with strategic oversight, focusing on scalable standards, automation, and risk-based processes in a fast-paced biotech environment.

Qualifications

• Bachelor’s or advanced degree in statistics, biostatistics, math, CS, data science or related quantitative discipline.
• At least 10 years of statistical programming experience in pharma/biotech/CRO with leadership, vendor oversight, and submissions.
• Advanced SAS programming skills (SAS/BASE, Macro, SQL, ODS) for clinical data analysis and reporting.
• Strong knowledge of CDISC standards (SDTM, ADaM, define.xml).
• Experience producing programming deliverables for clinical study reports and regulatory submissions.
• Experience with drug development processes, GCP/ICH, and electronic submissions.
• Experience with validation tools like Pinnacle 21 and risk-based issue resolution.
• Ability to manage multiple priorities, timelines, and cross-functional influence.

Responsibilities

• Provide technical and operational leadership for statistical programming across studies and programs.
• Oversee CROs and contractors with effective cross-functional partnership.
• Ensure quality, accuracy, timeliness, traceability and regulatory readiness of deliverables.
• Lead scalable standards, automation, and fit-for-purpose processes.
• Manage priorities, timelines, and risk to deliver high-quality outputs.

Skills

Statistical programming

Project leadership

Communication skills

Regulatory submissions

Risk management

Cross-functional leadership

CRO/vendor oversight

GCP/ICH knowledge

Python

XML

Education

Bachelor's degree

Advanced degree

Tools

Pinnacle 21

SAS

Python

XML

Git

Job description

Your mission

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 suited to 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.

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.