Senior Statistical Programmer

Role & responsibilities

• Provide advanced statistical programming support for complex clinical research projects.
• Develop, validate, and maintain clinical trial datasets and statistical outputs using SAS.
• Apply advanced Base SAS, SAS Macros, and PROC SQL programming techniques.
• Develop and support SDTM and ADaM datasets in accordance with CDISC standards.
• Program and validate Tables, Listings, and Figures (TLFs/TLGs) based on study specifications and statistical analysis plans.
• Translate protocols, SAPs, programming specifications, and mock shells into accurate programming deliverables.
• Perform data manipulation, derivations, QC, validation, troubleshooting, and review of clinical trial datasets and outputs.
• Prepare programming documentation, specifications, annotations, and related technical documentation.
• Ensure programming deliverables meet applicable GCP, FDA, EMA, ICH, and other regulatory requirements.
• Develop efficient, well-documented, and reproducible programming code.
• Collaborate with statisticians, biostatisticians, clinical data management, and other cross-functional teams.
• Manage multiple study deliverables and priorities while maintaining quality and timelines.
• Contribute to standardization and continuous improvement of statistical programming processes.

Preferred candidate profile

• 10+ years of relevant statistical programming experience, with 1012 years preferred.
• Candidates with 13–14 years of experience may also be considered if the technical fit is strong.
• Strong hands-on experience as a Statistical Programmer / Senior Statistical Programmer / Principal Statistical Programmer.
• Strong clinical statistical programming experience within a pharmaceutical, CRO, biotechnology, or clinical research environment.
• Strong proficiency in SAS, including Base SAS, SAS Macros, and PROC SQL.
• Strong hands-on experience with SDTM, ADaM, TLF/TLG, and CDISC standards.
• Good understanding of clinical trial data flow and programming requirements.
• Experience working with protocols, SAPs, programming specifications, mock shells, and clinical trial datasets.
• Experience with programming QC, validation, and regulatory-compliant deliverables.
• Knowledge of GCP and FDA/EMA/ICH regulatory requirements.
• R or Python experience is an added advantage but not mandatory.
• Additional exposure to Define.xml, CRF annotation, Pinnacle 21/OpenCDISC, and regulatory submissions is desirable.