Data Analysis Expert

2 weeks ago

pushkar, India beBeeStatisticalProgrammer Full time

Job OpportunityWe are seeking a talented statistical programmer to join our team. 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.Key Responsibilities:Develop, validate, and maintain ADaM datasets, TLFs, and other analytical outputs for clinical trials.Support Oncology studies by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables.Contribute to Integrated Summaries of Safety (ISS) and Integrated Summary of Efficacy (ISE) activities, including dataset integration, analysis, and documentation.Collaborate with statisticians, data managers, and clinical teams to ensure timely and quality delivery.Assist in regulatory submissions and responses to questions (RTQs), providing clear, traceable, and compliant programming outputs.Work closely with internal stakeholders to identify process improvements and implement changes.Ensure adherence to CDISC standards and good programming practices.RequirementsTo be considered for this role, you will need to have:A minimum of 4 years of experience in industrial programming, preferably in a clinical or biostatistics environment.Proficiency in R programming and strong understanding of SAS programming principles.Solid experience 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.BenefitsJoining our team as a statistical programmer offers numerous benefits, including:The opportunity to work on impactful Oncology research projects with global teams.A continuous learning and upskilling environment, where you can develop your skills and expertise.A collaborative and agile work culture, where you can contribute to process improvements and innovations.Exposure to end-to-end statistical programming lifecycle and regulatory submissions.

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