Key Responsibilities of the Role
The Statistical Programmer will be part of a Centre of Excellence (CoE) focused on Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses, supporting a dedicated Functional Service Provider (FSP) client.
Key responsibilities include:
Develop, validate, and maintain SAS programs for ISS/ISE pooled analyses across multiple clinical studies.
Create and deliver high-quality analysis datasets, tables, listings, and figures (TLFs) in accordance with client standards, study requirements, and regulatory expectations.
Support the integration and pooling of clinical trial data from multiple studies, ensuring consistency, traceability, and data quality.
Apply CDISC standards (SDTM and ADaM) to support integrated analyses and submission-ready outputs.
Collaborate closely with statisticians, programmers, data management teams, and client stakeholders to define analysis requirements and deliverables.
Perform quality control (QC)



and validation activities to ensure programming accuracy and compliance with internal and external standards.
Contribute to the development and continuous improvement of programming processes, tools, macros, and standards within the ISS/ISE CoE.
Support regulatory submissions, health authority requests, and other integrated evidence-generation activities as required.
Act as a subject matter expert for pooled analysis programming and provide guidance to other team members where appropriate.
Desirable Candidate Profile
We are looking for candidates who combine strong statistical programming capabilities with experience working in integrated analyses and regulatory environments.
Preferred qualifications and experience include:
Robust SAS programming experience within the pharmaceutical, biotechnology, or CRO industry.
Solid understanding and practical application of CDISC standards, including SDTM and ADaM.
Previous experience supporting ISS, ISE, pooled analyses, or other integrated clinical tri

📌 Senior/ Principal Programmer (India)
🏢 Veramed
📍 India