Dragonfly Therapeutics seeks an Senior Manager/Associate Director, Biostatistics to lead, develop, and implement statistical analyses to support our early development clinical trials, 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 Biometrics, is hands-on and requires excellent communication skills and frequent collaboration with multiple internal groups. The successful candidate can work independently and thrives in a proactive can-do culture. 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 Operations and Development team, responsible for all clinical study biostatistics deliverables
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 study design, methodology, analytic and operational approach, sample size and power considerations
Ensure that clinical trials meet statistical requirements (ICH, FDA, EMA guidelines) and are conducted with appropriate rigor
Provide ongoing reporting of clinical trial data as needed
Perform exploratory data analyses on patient subgroups
Collaborate with translational science and pharmacokinetic colleagues as needed to analyze early phase trial data
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 6+ years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 8+ years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience).
Ability to analyze, interpret, and summarize clinical and scientific data using a range of advanced statistical techniques for statistical analyses
Skill in 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
Experience with CRO vendor oversight is preferred
Experience in oncology and oncology statistical methods used is preferred
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 proactive, think strategically and manage multiple projects simultaneously
Ability to interact effectively with team members, proactively facilitating effective information exchange, with strong communication and problem-solving skills
About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
