Biostatistician

Biostatistician

Dragonfly Therapeutics seeks a Biostatistician (Director/Associate Director) to lead, develop, and implement statistical analyses to support our early development clinical trials (mainly Phase I and Phase II), and provide support to investigators and researchers on experimental design and statistical approaches, requirements, and scientific standards. This role will report to the Head of Clinical Development, is hands-on and requires frequent collaboration with multiple internal groups. The successful candidate can work independently and thrives in a proactive can-do culture. Deep scientific rigor and a thorough understanding of drug development are key success factors. The work will be fast-paced with evolving needs, requiring adaptability, curiosity, and grace under pressure. This role is an exciting opportunity to be a critical part of the clinical development group, involved in the design, execution, analysis, and reporting of Dragonfly’s clinical studies.

Responsibilities:

• Serve as the biostatistician in the clinical development team, responsible for all clinical study biostatistics deliverables
• Consult with investigators, interpret research requirements, and determine statistical analysis strategies
• Analyze and interpret data from various sources, using standard statistical analysis software to perform appropriate statistical analyses on clinical trial patient data
• Develop statistical sections of protocols and statistical analysis plans and assist in the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses from regulatory agencies
• Make recommendations on appropriate design, methodology, analytic and operational approach, sample size and power considerations
• Ensure that clinical development programs meet scientific, regulatory, and quality requirements
• Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring
• Prepare statistical reports for consistency, data quality, and data integrity
• Prepare tables and graphics summarizing descriptive statistics and analyses 
• Maintain knowledge of current and emerging trends in state-of-the-art statistical and analytic techniques
• Collaborate with, and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to meet project timelines and achieve goals
• Collaborate with cross-functional team to review study results and contribute scientific knowledge and analytical skills to the production of documents

Qualifications

• Ph.D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 7 years biopharmaceutical industry experience as a biostatistician or a Master’s degree in a relevant statistics field and 10 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience)
• Demonstrated ability to analyze, interpret, and summarize clinical and scientific data with minimal oversight, using a range of advanced statistic techniques for statistical analyses and preparing graphical data displays
• Knowledge of scientific approach and methodologies as well as principles, concepts, methods, and standards of statistical research
• Solid understanding of drug development, clinical research, study design, pharmacokinetics, and medical terminology
• Working knowledge of data management principles and regulatory requirements for clinical trials and medical research, including relevant ICH guidelines, US, EU and other regions’ regulations
• Strong organizational and analytical skills, with the ability to be highly proactive, think strategically and manage multiple projects simultaneously
• Ability to interact effectively with team members and senior leaders, proactively facilitating effective information exchange, with strong communication and problem-solving skills
• Ability to excel in a fast-paced, highly collaborative work environment with a multi-disciplinary and diverse team