Associate Director / Director, Statistical Programming

Job Summary

The Associate Director / Director, Statistical Programming will lead the statistical programming function across clinical studies and development programs. Responsibilities include ensuring the quality, accuracy, timeliness, traceability, and regulatory readiness of all programming deliverables such as SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, and responses to regulatory queries. This role combines hands‑on programming expertise with strategic oversight of CROs, contractors, and cross‑functional teams. It focuses on scalable standards, automation, and fit‑for‑purpose processes to support fast‑paced drug development. The incumbent will manage multiple priorities, anticipate risks, negotiate realistic timelines, and influence stakeholders in a matrixed environment. Candidates should have at least 10 years of statistical programming experience in pharma, biotech, or CRO settings, advanced SAS skills, deep knowledge of CDISC standards, and proven experience with regulatory submissions (BLA/NDA/MAA). Strong communication, leadership, and problem‑solving skills are essential.

Key Responsibilities

• The Associate Director / Director, Statistical Programming will lead the statistical programming function across clinical studies and development programs. Responsibilities include ensuring the quality, accuracy, timeliness, traceability, and regulatory readiness of all programming deliverables such as SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, and responses to regulatory queries. This role combines hands‑on programming expertise with strategic oversight of CROs, contractors, and cross‑functional teams. It focuses on scalable standards, automation, and fit‑for‑purpose processes to support fast‑paced drug development. The incumbent will manage multiple priorities, anticipate risks, negotiate realistic timelines, and influence stakeholders in a matrixed environment. Candidates should have at least 10 years of statistical programming experience in pharma, biotech, or CRO settings, advanced SAS skills, deep knowledge of CDISC standards, and proven experience with regulatory submissions (BLA/NDA/MAA). Strong communication, leadership, and problem‑solving skills are essential.

About the Role

This role is ideal for someone who enjoys combining strategy, content, data and execution. You will work with cross-functional teams and contribute directly to the company’s digital growth in Kolkata and surrounding areas.

Job Requirements

• SAS programming
• CDISC standards
• Statistical programming
• Regulatory submissions
• Clinical data analysis

Required Skills