Remote Associate Director, Statistical Programming Leader

MeiraGTx; United States; Remote; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Statistical programming

Project leadership

Communication skills

Regulatory submissions

Risk management

Cross-functional leadership

CRO/vendor oversight

GCP/ICH knowledge

Python

XML

Ausbildung

Bachelor's degree

Advanced degree

Tools

Pinnacle 21

SAS

Python

XML

Git

Jobbeschreibung

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.