Remote Associate Director, Statistical Programming

MeiraGTx; New York (NY); Remote; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

MeiraGTx is seeking an Associate Director/Director of Statistical Programming to provide hands-on leadership across clinical studies and development programs. You will ensure regulatory-ready programming deliverables, drive automation, and oversee CROs with a strategic, scalable approach.

The role requires strong SAS skills, deep CDISC/SDTM/ADaM knowledge, and a track record in regulatory submissions. Remote work within US time zones is supported, with some travel as needed.

Qualifikationen

• Bachelor’s or advanced degree in a quantitative discipline such as Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences.

Aufgaben

• Provide leadership for statistical programming across clinical studies and development programs.
• Ensure regulatory-ready programming deliverables (SDTM/ADaM, tables, listings, figures, define.xml).
• Manage CROs/contractors and cross-functional collaboration for scalable standards and automation.
• Oversee quality, traceability and submission readiness for regulatory questions.

Kenntnisse

Leadership

Regulatory submissions

CRO oversight

Cross-functional influence

Programming quality & automation

Ausbildung

Bachelor's or advanced degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences or related

Tools

Pinnacle 21

SAS

R

Python

XML

Git

Jobbeschreibung

MeiraGTx is seeking an Associate Director/Director of Statistical Programming to provide hands-on leadership across clinical studies and development programs. You will ensure regulatory-ready programming deliverables, drive automation, and oversee CROs with a strategic, scalable approach.

The role requires strong SAS skills, deep CDISC/SDTM/ADaM knowledge, and a track record in regulatory submissions. Remote work within US time zones is supported, with some travel as needed.