Director, Statistical Programming — Remote Leadership

MeiraGTx Limited; United States; Remote; USD 180,000 - 250,000; Full time

Job summary

MeiraGTx Limited seeks an Associate Director/Director, Statistical Programming to lead programming for clinical studies and development programs. You will ensure quality, timeliness, traceability, and regulatory readiness of SDTM/ADaM deliverables and define.xml, while managing CROs and cross-functional partners.

The role blends hands-on programming with strategic oversight in a biotech setting, focusing on scalable standards, automation, and compliant reporting for regulatory submissions.

Qualifications

• PhD/MD or advanced degree in a quantitative field is preferred.
• 10+ years in statistical programming within pharma/biotech/CRO.
• Strong SAS programming expertise for clinical data analysis and reporting.
• Deep knowledge of CDISC SDTM/ADaM and define.xml.
• Experience leading programs and vendor management for regulatory submissions.
• Familiarity with GCP/ICH guidance and electronic submission expectations.
• Experience with Pinnacle 21 and risk-based validation.

Responsibilities

• Provide technical and operational leadership for statistical programming across studies.
• Oversee CROs/contractors and ensure regulatory readiness of deliverables.
• Guide SDTM/ADaM datasets, tables, listings, figures, and define.xml.
• Lead integrated and exploratory analyses and regulatory responses.
• Shape scalable, automation-focused programming standards.

Skills

Statistical programming

SAS programming

SDTM/ADaM

Regulatory submissions

Vendor oversight

Leadership

GCP/ICH

Education

Statistics/biostatistics degree

Tools

Pinnacle 21

R

Python

Job description

MeiraGTx Limited seeks an Associate Director/Director, Statistical Programming to lead programming for clinical studies and development programs. You will ensure quality, timeliness, traceability, and regulatory readiness of SDTM/ADaM deliverables and define.xml, while managing CROs and cross-functional partners.

The role blends hands-on programming with strategic oversight in a biotech setting, focusing on scalable standards, automation, and compliant reporting for regulatory submissions.