Senior Statistical Programmer

Role & 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

Preferred candidate profile

• Bachelor's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Required or
• Master's 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. High
• In depth knowledge of CDISC SDTM and ADaM standards. High
• Experience supporting clinical trial reporting and preparing data for regulatory submissions as FDA, EMA. High
• Excellent attention to detail, problem solving, and communication skills. High
• Ability to work independently and collaboratively in a fast paced environment. High