Senior Biostatistician

Pulse Biosciences, Inc.

Sr. Biostatistician providing advanced statistical expertise to support clinical studies at Pulse Biosciences.

Posted 5/12/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

statistical methodologiessample size calculationsdata collection methodsstatistical analysis plans (SAPs)advanced statistical analysesdata processingstatistical programming (SAS, Python)statistical techniquesregulatory submissionsclinical trial design

Soft Skills

oral communicationwritten communicationcritical thinkinginitiativeteam collaborationflexibilityjudgmentconscientiousnessmulti-taskingadaptability

Certifications

PhD in BiostatisticsPhD in Statistics