Principal Biostatistical Analyst

Job Title: Statistical ProgrammerJob Summary:The successful candidate will be responsible for developing, validating, and maintaining ADaM datasets, TLFs, and other analytical outputs for clinical trials.They will also support Oncology studies by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables.Additionally, they will contribute to ISS/ISE activities, including dataset integration, analysis, and documentation.Key Responsibilities:Develop ADaM datasets, TLFs, and other analytical outputs for clinical trials.Validate and maintain ADaM datasets, TLFs, and other analytical outputs.Support Oncology studies by ensuring accuracy, consistency, and regulatory compliance.Contribute to ISS/ISE activities, including dataset integration, analysis, and documentation.Work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery.Assist in regulatory submissions and RTQs, providing clear, traceable, and compliant programming outputs.Collaborate in an agile environment, participating in sprint meetings, planning, and continuous improvement discussions.Troubleshoot data/programming issues and propose process enhancements.Ensure adherence to CDISC standards, good programming practices, and audit-ready documentation.Required Skills & Qualifications:4-14 years of industrial experience.Proficiency in R programming.Intermediate candidates with strong learning intent and ability to upskill quickly will also be considered.Solid experience in SAS programming, especially in a clinical/biostatistics environment.Hands-on expertise in ADaM dataset development and TLF programming.Good understanding of CDISC standards and clinical trial data flow.Strong problem-solving skills, attention to detail, and ability to work in cross-functional teams.Benefits:Opportunity to work on impactful Oncology research with global teams.Continuous learning and upskilling environment.Collaborative, agile work culture.Exposure to end-to-end statistical programming lifecycle and regulatory submissions.Why this job?This is a challenging role that requires a high degree of technical skill and business acumen.The ideal candidate will be able to develop and implement effective solutions to complex problems.They will also be able to communicate effectively with stakeholders at all levels.As part of our team, you will have the opportunity to make a real impact on our business and customers.