Sr. Biostatistician

Pulse Biosciences

6d•Hybrid

About The Position

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.

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 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.

Nice To Haves

Ability to lift 10-15 pounds.

Responsibilities

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.