Sr. Biostatistician

About the Role

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.

To Make an Impact, You Will:

• 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.

To Excel, You Will Bring:

• 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.