Sr. Biostatistician

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.  The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.

• →Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
• →Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
• →Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• →Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• →Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• →Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
• →Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce. 

As a key member of the Clinical Affairs department, the Sr. Biostatistician provides advanced statistical expertise to support the design, conduct, and analysis of clinical studies, ranging from early pre-market to post-market evidence generation. The Sr. Biostatistician is the statistical subject matter expert working in cross-functional teams, managing roadmaps and priorities to ensure timely and high-quality delivery of results.

• Develop statistical methodologies, protocols, and sample size calculations for pre-market and post-market clinical studies.
• Plan methods to collect data and develop or review case report forms to ensure compatibility with plan design. 
• Evaluate reliability and validity of source information, apply weightings to raw data, and organize results in form appropriate to software requirements. 
• Designs clinical trials, analyzes study data to validate device safety and efficacy, and creates Statistical Analysis Plans (SAPs).
• Perform advanced statistical analyses using appropriate methodologies.
• Interpret results and provide strategic insights.
• Review clinical literature and analyze Real-World Evidence (RWE) to set performance goals.
• Write reports summarizing trial outcome statistics, indicating sources of data and limits on reliability and usability, for in-house, regulatory and publication target audiences. 
• Prepare statistical reports for regulatory submissions (FDA, CE Mark, other regulatory authorities like TUV) and address regulatory inquiries.
• Performs analysis and generates visual/tabular data for scientific presentations and publications.
• Collaborate with cross-functional team members (clinical affairs, data management, pre-clinical and R&D engineers) to define endpoints, analyze safety reporting, and prepare for submissions.to ensure data integrity and accurate analyses.
• Develop statistical tables and data summaries as needed.
• Review project database structures, edit checks and data management coding conventions.
• Ensure compliance with industry standards and guidelines.
• May attend relevant scientific and/or medical meetings. 
• Support publication of study findings.

• 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 and understanding of regulatory guidelines, submissions and documentation.
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas.
• Must have advanced data processing and/or computer programming skills.
• Advanced knowledge or statistical techniques, terms, methodologies and application software.
• Working knowledge of FDA data reporting requirements.
• Proficiency is statistical programming languages (e.g., SAS or Python).
• Proven expertise in advanced and complex statistical methodologies, including experience with adaptive designs or Bayesian methods.
• Proficient knowledge and skill in Microsoft Office Suite applications.
• Excellent oral and written communication skills with critical thinking skills.
• Ability to work conscientiously and with minimal direction, using good judgement, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
• Ability to lift 10-15 pounds.

Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.  To learn more about us, visit our website at www.pulsebiosciences.com.

We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.