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Sr. Biostatistician

1 hour, 46 minutes ago
United States
Full-time
Senior
Data Scientist
Data Science and Analytics
Python Statistics
Apply Now
Pulse Biosciences

Pulse Biosciences

Powering the next generation in bioelectric medicine with Nanosecond Pulse Field Ablation technology. Pulse Biosciences pioneers in the research, design and production of our patented Nanosecond Pulsed Field Ablation™ (nsPFA™) technology for use in hig...

Health Care Providers & Services
51-250
Founded 2016
$80M raised
View All Jobs 4

Description

  • Develop statistical methodologies, protocols, and sample size calculations for pre-market and post-market clinical studies.
  • Plan data collection methods and develop or review case report forms to match the study design.
  • Design clinical trials, analyze study data to assess device safety and efficacy, and create statistical analysis plans (SAPs).
  • Perform advanced statistical analyses and interpret results to provide strategic insights.
  • Review clinical literature and real-world evidence to establish performance goals.
  • Prepare statistical reports and documentation for regulatory submissions, including FDA, CE Mark, and other authorities.
  • Generate statistical tables, visual outputs, and data summaries for scientific presentations and publications.
  • Collaborate with clinical affairs, data management, pre-clinical, and R&D teams to define endpoints, ensure data integrity, and support submissions.
  • Review database structures, edit checks, and data management coding conventions.
  • Support publication of study findings and may attend scientific or medical meetings.

Requirements

  • PhD in Biostatistics, Statistics, or related experience required.
  • 8+ years of relevant experience in medical device or pharmaceutical clinical trials.
  • Strong knowledge of clinical trial design and statistical methodologies.
  • Experience with regulatory guidelines, submissions, and documentation.
  • In-depth knowledge of study designs and statistical analysis applications in one or more therapeutic areas.
  • Advanced data processing and/or computer programming skills.
  • Proficiency in statistical programming languages such as SAS or Python.
  • Advanced knowledge of statistical techniques, terminology, methodologies, and application software.
  • Working knowledge of FDA data reporting requirements.
  • Experience with advanced statistical methodologies, including adaptive designs or Bayesian methods preferred.
  • Proficient with Microsoft Office Suite.
  • Excellent oral and written communication skills, with strong critical thinking.
  • Ability to work independently, manage multiple priorities, and adapt to changing requirements in a fast-paced environment.
  • Ability to lift 10–15 pounds.

Benefits

  • A variety of health insurance plans and supplemental insurance options.
  • 401(k) retirement savings plan.
  • Stock option awards and an Employee Stock Purchase Plan (ESPP).
  • Paid time off and paid holidays.
  • Flexible work schedule.
  • Wellness program, including onsite gym and mindfulness classes.
  • A learning culture with professional and personal growth opportunities.
  • A respectful, diverse, and inclusive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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