Principal Statistical Programmer (8-10 years)

Principal Statistical Programmer

Experience: 810 Years

Location: Hyderabad

Role Overview

The Principal Statistical Programmer will lead programming activities across clinical studies and regulatory submissions, ensuring high-quality SDTM, ADaM datasets and TLF outputs aligned with CDISC standards. The role requires strong leadership in study programming, regulatory submission support, and cross-functional collaboration with Biostatistics and Clinical teams.

Key Responsibilities

• Lead development and validation of SDTM and ADaM datasets in accordance with CDISC standards.
• Lead programming and validation of Tables, Listings, and Figures (TLFs) supporting:
• Clinical Study Reports (CSR)
• Interim analyses
• DSUR and DMC outputs
• Investigator Brochure updates
• Conference publications and exploratory analyses
• Regulatory submissions
• Create and review SDTM CRF annotations and dataset specifications.
• Create and review ADaM dataset specifications ensuring consistency with Protocol, SAP, and mock shells.
• Create and review define.xml for regulatory submissions.
• Provide advanced programming support and develop statistical programming utilities/macros.
• Review critical study documentation including Protocol, SAP, mock shells, data transfer specifications, and unblinding plans.
• Support NDA/BLA regulatory filings, including ISS/ISE dataset integration.
• Mentor junior programmers and provide technical oversight.

Technical Skills

• Advanced expertise in SAS programming and Macro development.
• Deep knowledge of CDISC standards (SDTM, ADaM) and submission requirements.
• Strong experience in TLF programming and validation.
• Experience supporting regulatory submissions (NDA/BLA) including ISS/ISE datasets.
• Experience with BIMO submissions and safety reporting preferred.
• Exposure to Oncology therapeutic area preferred.
• Knowledge of R programming is desirable.
• Strong understanding of ICH guidelines and regulatory requirements.

Qualification

• Bachelors degree or equivalent in Statistics, Mathematics, Computer Science, Public Health, or related quantitative discipline.
• 810 years of statistical programming experience in clinical trials.
• Proven ability to independently lead study-level programming activities.