Associate Director I/II, Real World Data Statistics

Lead design and implementation of advanced statistical analyses using registry and real-world data for regulatory submissions in rare diseases.

Oversee development of regulatory-quality deliverables aligned with FDA, EMA, and global guidelines ensuring reproducibility and audit readiness.

Provide leadership across functions and mentor Real World Data Statisticians to build technical expertise and ensure regulatory compliance.

PhD with minimum 7 years relevant industry experience or Master’s degree with minimum 10 years relevant industry experience in statistics, biostatistics, epidemiology or related field.

Expert proficiency with R and/or SAS; understanding of SQL or Python for data engineering and validation.

Experience in generating real-world evidence for rare disease programs and leading regulatory submissions.

Location: Must work on-site at Manyata Tech Park, Bangalore (minimum 3 days per week).

Experienced in applying advanced statistical methodologies to registry-based real-world data for regulatory-grade evidence generation.

Proven ability to influence and communicate complex statistical analyses to senior leadership and regulatory authorities globally.

Demonstrated leadership in collaborative, cross-functional settings with external stakeholders including registry investigators and regulatory consultants.