Senior Statistical Programmer

Job Title: Senior Statistical Programmer

Location: IN/EU(Hybrid/Remote)

Employment Type: Full-Time

Experience Required: 7+ Years

Job Summary

We are looking for a strong Senior Statistical Programmer. The role requires hands-on expertise in SAS-based analysis and reporting, CDISC-compliant SDTM and ADaM development, and delivery of high-quality Tables, Listings, and Figures (TLFs) in a regulated clinical research environment.

Key Responsibilities

• Perform end-to-end statistical programming for clinical trial data analysis and reporting using SAS.
• Lead the development, validation, and maintenance of SDTM and ADaM datasets in compliance with CDISC standards.
• Program and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
• Support safety and efficacy analyses, including ISS and ISE deliverables.
• Develop complex ad-hoc analyses and reports from raw clinical data.
• Ensure production-quality programming through independent QC and validation.
• Collaborate closely with statisticians, data management, and cross-functional teams.
• Demonstrate strong ownership, accountability, and adherence to project timelines.
• Adapt effectively to changing priorities in a fast-paced clinical development environment.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Statistics, Computer Science, or a related field.
• Minimum 7+ years of hands-on experience in clinical trial statistical programming.
• Strong proficiency in SAS (Base SAS, Macros, SAS/STAT, SAS/GRAPH).
• Solid experience with CDISC standards (SDTM, ADaM), including mapping, development, and validation.
• Experience supporting regulatory submissions, including ISS and ISE.
• Familiarity with eCTD deliverables, Define.xml, and dataset documentation.
• Strong analytical, problem-solving, and documentation skills.
• Ability to work independently and as part of a collaborative team.

Nice to Have

• Experience working in global or client-facing project environments.
• Exposure to mentoring junior programmers or providing QC oversight.
• Prior involvement in submission-driven studies.