Principal Biostatistician

How you will make an impact:

• Statistical lead on multiple clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses
• Collaborate with core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
• Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
• Research and recommend novel statistical methodology and/or approaches
• Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team
• Compile technical documents for internal and external audits
• Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)
• Lead the efforts of data analysis for data monitoring committee as needed
• Mentor Junior statisticians and work with management in resource allocation and budget/timeline development activities

What you'll need (Required):

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience
• Master's Degree or equivalent in Statistics, Biostatistics, or related field, 5 years' experience of previous analytical experience in clinical trials

What else we look for (Preferred):

• Experience with machine learning and AI agent development
• Experience developing machine learning dashboards
• Advanced proficiency in Python
• Proficiency in R and SAS
• Deep familiarity with clinical data and/or real-world evidence (RWE)
• Experience applying machine learning to clinical data
• Expertise in causal inference methodologies for real-world evidence
• Experience with survival analysis
• Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
• Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Keeps abreast of new developments in statistics and regulatory guidance
• Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Strong leadership skills and ability to influence change
• Ability to provide training and coaching to lower level employees
• Experience in facilitating change, including collaboration with management and executive stakeholders