Senior Biostatistician

Overview:

Key Responsibilities:

• Lead statistical planning analysis and reporting for clinical studies and regulatory submissions
• Develop statistical analysis plans and contribute to study protocols
• Perform statistical analyses and interpret results for efficacy safety and outcomes research
• Provide input for sample size calculations and study design
• Conduct statistical programming for analysis datasets and statistical outputs
• Review and validate statistical work performed by other statisticians or programming team
• Contribute to the development and validation of statistical analysis software
• Communicate statistical findings to nonstatistical audiences
• Interact with regulatory agencies and participate in meetings and submissions
• Provide mentorship and guidance to junior statisticians
• Contribute to the development and review of statistical standard operating procedures
• Stay informed about latest statistical methodologies and regulations
• Contribute to process improvement and efficiency within the biostatistics function
• Collaborate with external research partners and contribute to publications and presentations
• Ensure adherence to regulatory and industry standards for statistical work

Required Qualifications:

• Masters or Ph.D. degree in Biostatistics Statistics or related field
• Minimum of 5 years of experience in biostatistics within the pharmaceutical biotech or CRO industry
• Expertise in statistical methods for clinical trials and observational studies
• Proficiency in statistical software packages such as SAS R or STATA
• Experience in statistical programming and data manipulation
• Strong understanding of regulatory requirements for clinical trial conduct and submissions
• Excellent communication and presentation skills for both technical and nontechnical audiences
• Ability to work effectively in crossfunctional teams and with external collaborators
• Experience in mentoring and guiding junior statisticians
• Ability to manage multiple projects and prioritize effectively
• Publication record in peerreviewed journals preferred
• Strong problemsolving skills and attention to detail
• Adherence to ethical and professional standards in statistical practice
• Adaptability to changing project needs and timelines
• Continual learning and application of new statistical methods and technologies

biostatistics,clinical trials,statistical software,data analysis,statistical modeling,observational studies