Job Details:
Job Title:Senior Statistical Programmer (CDISC focus)

Location: India

Job Type: Full-Time

Company Overview:
Cencorais a leading organization in the pharmaceutical/biotechnology industry, dedicated to advancing healthcare through innovative research and development. With expertise spanning supply chain innovation, clinical trial support, and strategic consulting, we are committed to improving patient outcomes and are looking for a talented Senior Statistical Programmer to join our energetic team.

Job Summary:
Key Responsibilities:
- Lead and contribute to the development, review, and documentation of CDISC-compliant dataset specifications and data sets, with primary focus on SDTM and ADaM; serve as an SME for CDISC standards governance.
- Perform quality control (QC) of CDISC dataset specifications, derived datasets, and standard or custom tables, figures, and listings (TFLs) to ensure quality and compliance with CDISC standards and regulatory guidelines.
- Generate or review TFLs for clinical study reports and regulatory submissions.




- Perform statistical programming using SAS and R, ensuring compliance with CDISC standards.
- Prepare submission-ready regulatory documentation including Define.xml, Study Data Reviewer’s Guide (SDRG), Analysis Data Reviewer’s Guide (ADRG), and other documentation as required (e.g., ISS/ISE), in alignment with regulatory authority expectations (e.g., FDA, EMA).
- Contribute to process optimization (e.g., SAS macro libraries, code or documentation templates, standard operating procedures (SOPs)), development of a modern programming ecosystem (e.g., R adoption, automation, AI integration), and internal training development and delivery to build a consistent, scalable internal CDISC programming infrastructure.
- Provide technical support to other team members to ensure that they have the required knowledge to fulfil their duties.
- Work collaboratively with statisticians and/or Data Management function to resolve all data i

📌 Senior Statistical Programmer (Noida)
🏢 Cencora
📍 Noida