Sr Statistical Programmer

Job Summary

The Senior Statistical Programmer is responsible for programming, validating, and delivering statistical datasets and outputs to support clinical trial analysis and regulatory submissions. Working closely with Biostatistics, Data Management, and Clinical teams, this role contributes to the delivery of high-quality, CDISC-compliant datasets and analysis results for Phase I-IV clinical trials. This position requires strong proficiency in SAS programming, a solid understanding of CDISC standards (SDTM and ADaM), and experience working in a regulated environment.

Responsibilities

• Programming & Validation: Develop, test, and validate SDTM and ADaM datasets according to CDISC standards.
• Program Tables, Listings, and Figures (TLFs) in support of clinical study reports (CSRs) and regulatory submissions.
• Translate statistical analysis plans (SAPs) into accurate and efficient code.
• Project Support: Serve as the lead programmer on individual studies or studies within a program.
• Collaborate with cross functional teams including Biostatisticians, Clinical Data Managers, and Regulatory personnel.
• Ensure timely and accurate delivery of programming deliverables to support clinical timelines.
• Quality & Compliance: Conduct independent quality checks on programming outputs.
• Maintain programming documentation according to internal SOPs and regulatory guidelines.
• Ensure compliance with GCP, ICH, and 21 CFR Part 11 standards.
• Process Improvement: Contribute to the development and refinement of internal programming standards, macros, and reusable code libraries.
• Identify opportunities to optimize workflows and improve efficiency within the programming team.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• Master's Degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• Preferred 4-6 years as a statistical programmer in a pharmaceutical, biotech, or CRO environment.
• Strong programming skills in SAS as Base, Macro, SQL; familiarity with R or Python is a plus.
• In-depth knowledge of CDISC SDTM and ADaM standards.
• Experience supporting clinical trial reporting and preparing data for regulatory submissions (FDA, EMA).
• Excellent attention to detail, problem solving, and communication skills.
• Ability to work independently and collaboratively in a fast paced environment.

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