Clinical Biostatistician



Data Science
Remote · Boston, MA, USA
Posted on Tuesday, April 11, 2023

Who We Are

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

Where You Fit

We're looking for experienced biostatisticians to lead statistical analysis activities for clinical product development. Reporting into the Director of Clinical Data Science, the role requires maintaining a steady, open dialogue regarding study execution with internal and external regulatory teams, designing analysis plans that cover timelines, data quality, and interpretation of the results. The role will drive PathAI’s growth by leading the company in its goals of achieving regulatory approval of first-in-class AI models, and developing study designs in collaboration with our biopharma partners. The right candidate will be a mission-driven, rigorous statistician with demonstrated expertise in study design.

What You’ll Do

  • Lead biostatistics efforts in a team setting of fellow AI researchers, clinical scientists, pathologists, and data managers for PathAI sponsor studies.
  • Development Services studies, and in platform and algorithm research and development.
  • Determine innovative study designs, appropriate sample size, statistical tests and methods for both evaluating statistical hypotheses related to the performance of our AI tools and viewing platforms.
  • Leads optimization of statistical methods for the design, conduct, analysis, and reporting of clinical studies, and to address identified or potential statistical issues arising in studies or programs
  • Leads SAS programming for analyses of clinical studies.
  • Be accountable for all statistical aspects of assigned clinical development programs or functional area, including clinical development plans, protocols and regulatory submissions
  • Work with other functional areas across PathAI to set product development strategies that increase the probability of success, and create an innovative environment, agile and clear processes, and high levels of productivity.
  • Descriptive and exploratory analysis of cross-sectional and longitudinal data.
  • Participate in interactions with the regulatory agencies and corporate partners on the biostatistical aspects of product development

What You Bring

  • PhD in Biostatistics/Statistics or equivalent with a minimum of 3+ years relevant work experience or MS in Biostatistics/Statistics, or equivalent with a minimum of 5+ years relevant experience.
  • In-depth experiences in the clinical development process and the role of biostatistics to design studies and experiments to generate the most relevant evidence.
  • In-depth knowledge of FDA, EMA and ICH regulations and guidelines related to data management and analysis.
  • Knowledge of CDISC standards
  • Experience leading statistical efforts for a late-phase development program
  • Experience as a Biostatistics lead for 510ks, PMAs, or other regulatory submissions
  • Experience in direct interactions with FDA advisory committee a plus.
  • Proficiency in SAS a must, and proficiency in Python strongly desired.
  • Capability to conduct systematic analyses to evaluate multiple hypotheses and prioritize clinically-relevant questions.
  • Excellent problem-solving and collaboration skills.
  • Strong communication, data presentation, and visualization skills.
  • Comfort working with industry, academic, and regulatory leaders.

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.

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