Statistical Programmer (5-8 Years)

Senior Statistical Programmer

Experience: 58 Years

Location: Hyderabad

Role Overview

The Senior Statistical Programmer will support clinical trial programming activities including SDTM, ADaM dataset development and TLF programming in compliance with CDISC standards. The role requires hands-on programming and collaboration with Biostatistics to deliver high-quality outputs for clinical study reporting.

Key Responsibilities

• Develop and validate SDTM and ADaM datasets in accordance with CDISC standards.
• Program and validate Tables, Listings, and Figures (TLFs) to support:
• Clinical Study Reports (CSR)
• Interim analyses
• DSUR and DMC outputs
• Investigator Brochure (IB) updates
• Exploratory analyses and publications
• Create SDTM CRF annotations and support development of SDTM dataset specifications.
• Contribute to ADaM dataset development aligned with Protocol, SAP, and mock shells.
• Support define.xml creation and validation.
• Provide programming support to Biostatistics teams for statistical analysis.
• Review study-related documentation including Protocol, SAP, mock shells, and data transfer specifications.
• Participate in safety reporting and regulatory documentation support.

Technical Skills

• Strong hands-on experience in SAS programming and Macro development.
• Experience in end-to-end programming including SDTM, ADaM, and TLF generation.
• Experience with BIMO submissions and ISS/ISE pooling preferred.
• Knowledge of Oncology therapeutic area is desirable.
• Exposure to HTA analyses preferred.
• Working knowledge of R programming is a plus.
• Good understanding of ICH guidelines and CDISC standards.