Senior Clinical Programmer

Responsibilities

• Design and develop custom applications, scripts, and tools for clinical data collection, processing, and analysis
• Establish and enforce data standardization practices (e.g., CDISC, SDTM, ADaM)
• Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs
• Audit unusual circumstances and use sophisticated analytical techniques to identify and resolve complex data issues
• Create and maintain data integration pipelines between clinical systems and internal databases
• Program, validate, and maintain table listings and figures (TLFs) for clinical study reports and regulatory submissions
• Provide technical guidance to junior programmers on clinical data processing methodologies

Requirements

• Bachelor's degree in computer science, statistics, life sciences, or a related field with a minimum of 5 years of related experience; or Master's degree with 3 years of experience; or equivalent work experience.
• Proficiency in R, with experience in other relevant programming languages (e.g., Python, SQL, SAS).
• Comprehensive understanding of clinical trial processes, data flow, and clinical trial data standards (e.g., CDISC SDTM, ADaM).
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and explain technical concepts to non-technical stakeholders.
• Knowledge of regulatory requirements and experience preparing programming deliverables for submissions to regulatory agencies.

Preferred Skills

• Experience with data visualization tools (e.g., Power BI, Tableau)
• Proficiency in version control systems (e.g., Git) and collaborative development practices
• Experience mentoring junior programmers and conducting code reviews
• Familiarity with cloud-based data platforms and integration technologies
• Experience with software validation per FDA guidelines
• Knowledge of machine learning or advanced analytics techniques applicable to clinical data

Pay

Salary range: $145,604- $156,347 (Annual Base Salary)

The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.