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Principal Biostatistician



Data Science
pathai, madhya pradesh, india · Boston, MA, USA
Posted on Saturday, September 2, 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 an experienced clinical biostatistician to lead statistical analysis activities for clinical product development and regulatory submissions. The role requires maintaining a steady, open dialogue with internal teams and regulatory agencies, designing and implementing statistical analysis plans, and providing statistical support from development to submission, including post market studies. 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 biostatistician with demonstrated expertise in study design.

What You’ll Do

  • Lead biostatistics efforts in a team setting of fellow scientists and machine learning engineers.

  • Determine innovative study designs, appropriate statistical tests and methods for both evaluating and generating statistical hypotheses to support validation studies.

  • Work with Clinical Science and Regulatory functions to analyze/format validation study results and communicate them to FDA and other regulatory agencies through clinical study reports, direct interaction and submission documents.

  • Work with other functional areas across PathAI to support development and evidence building strategies that increase the probability of success, and create an innovative environment.

  • Lead interactions with regulatory agencies and corporate partners on the biostatistical aspects of product development and validation.

What You’ll Need:

  • PhD in Biostatistics/Statistics or equivalent with 5+ years relevant work experience or MS in Biostatistics/Statistics, or equivalent with 10+ years relevant experience.

  • In-depth experiences in the clinical development and/or medical device submission process and the role of biostatistics to design studies and experiments to generate the most relevant evidence.

  • Expertise in statistical programming languages (e.g., SAS, R).

  • 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.

  • Ability to individually contribute, as well as eventually manage a team of biostatisticians and/or programmers.

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.