Sr Statistical Programmer - Contractor

Job Summary


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

• Bachelors Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• Required or Masters Degree 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.
• Required 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 as 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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