Senior Statistical Analyst

3 days ago

bhavnagar, India beBeeStatistical Full time

Job OpportunityWe are seeking a seasoned Senior Statistical Analyst to join our team.Key Responsibilities:Data Analysis: Develop and implement statistical models, generate datasets, and create complex listings and tables.SAS Programming: Write and maintain high-quality SAS programs tailored to clinical development programs' needs.Project Management: Collaborate with cross-functional teams to oversee CRO's statistical programming deliverables, ensure timely completion, and meet project goals.Regulatory Compliance: Stay up-to-date on FDA regulations affecting the reporting of clinical trial data and adhere to good clinical practice guidelines.Tool Development: Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.Clinical Study Reports: Support the preparation of clinical study reports, regulatory submissions, publications, and annual DSURs.About the Role:Collaboration: Work closely with internal and external functions (e.g. CROs, software vendors, clinical development partners) to ensure meeting project timelines and goals.Documentation: Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.Data Transfer: Author data transfer specifications for external vendor data.Validation Plans: Participate in the development of CRFs, edit check specifications, and data validation plans.Requirements:Expertise: Proven expertise in statistical analysis, programming, and project management.Certifications: Familiarity with relevant certifications such as R or SAS.Education: Bachelor's degree in a quantitative field or equivalent experience.Benefits:Professional Growth: Opportunities for career advancement and professional growth.Work-Life Balance: Flexible work arrangements to support work-life balance.Team Environment: Collaborative team environment with opportunities for networking and learning.

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