Job Details

Job Title: Senior Statistical Programmer (CDISC focus)

Location: India

Job Type: Full-Time
Job Summary

We are seeking a highly skilled Senior Statistical Programmer with extensive experience in CDISC-compliant statistical programming. The Statistical Programmer will act as a subject matter expert (SME) in CDISC data standards and a project manager responsible for coordinating the preparation, execution, reporting and documentation of statistical programming activities internally and externally. This role requires deep expertise in CDISC-compliant programming, thorough understanding of regulatory submission requirements of data packages, and the ability to act as programming project lead across internal and external teams.
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 contemporary programming ecosystem (e.g., R adoption, automation, AI integration), and internal training development and delivery to build a consistent, scalable internal CDISC programming infrastructure.

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