Principal Statistical Programmer in Bangalore, भारत

ICON seeks a Principal Statistical Programmer to lead statistical programming solutions for clinical trials and regulatory submissions. The role involves developing validated statistical programs, collaborating with cross-functional teams, mentoring junior programmers, and ensuring compliance with regulatory standards.

Responsibilities

• Design and implement statistical programming solutions supporting clinical trials and regulatory submissions
• Develop and validate statistical programs for data analysis and reporting with regulatory compliance
• Collaborate with biostatisticians and clinical teams to define requirements and align with study objectives
• Mentor and guide junior statistical programmers to foster continuous improvement
• Monitor industry trends and advancements to drive innovation in programming approaches

Requirements

• 7+ years statistical programming experience in pharmaceutical, biotechnology, or CRO settings
• Strong SAS programming expertise with clinical trial and statistical analysis experience
• Knowledge of R programming with willingness to develop proficiency
• Comprehensive understanding of CDISC standards (SDTM and ADaM)
• Experience developing, validating, and maintaining production-quality code
• Hands-on experience with Pinnacle 21 for CDISC compliance and data validation
• Strong analytical, problem-solving, and cross-functional collaboration skills