Manager, Biostatistics

Responsibilities

• Provide expert technical and strategic leadership in the design, analysis, and interpretation of complex clinical and real-world data studies, with a focus on high-impact projects.
• Collaborate cross-functionally with Engineering, Clinical/Medical, Data Science, and other stakeholders to drive project success and translate research into actionable business and clinical insights.
• Lead development on statistical analysis plans - sample size and power calculations, and propose accurate and efficient statistical methodologies.
• Oversee and independently execute statistical analyses for studies of high complexity, proactively identifying and addressing methodological challenges and improving or extending standard methods as needed.
• Provide statistical support required for any regulatory submissions.
• Independent work on complex problems, and selecting and adapting novel methods as appropriate.
• Collaborate in an interdisciplinary role with scientists and engineers to translate research into actionable insights for our clients.
• Stay current with advances in statistical methodologies, regulatory requirements, and industry best practices relevant to clinical trials and real-world data studies.
• Comply with all regulations and Company procedures.
• Mentor and provide guidance to junior and senior biostatisticians, offering both high-level project leadership and detailed technical review (e.g., SAP review, code validation).

Requirements

• Ph.D. or Masters Degree in Biostatistics, Statistics, or a related field with 4+ years (Ph.D.) / 6+ years (MS/MA) relevant industry experience.
• Demonstrated expertise in advanced statistical analysis methods, experimental design, and survival analysis, with strong business domain knowledge in oncology, cardiology, and/or genomics.
• Proven ability to improve or extend standard statistical design and analysis methods to address project-specific challenges.
• Experience developing and reviewing statistical analysis plans (SAPs) and independently running analyses for complex studies with minimal oversight.
• Proficiency in R and other relevant statistical software, with experience in code review and validation.
• Excellent communication, organizational, and problem-solving skills.

Qualifications

• Expertise in advanced statistical analysis methods, experimental design, and survival analysis, with strong business domain knowledge in oncology, cardiology, and/or genomics.
• Proven ability to improve or extend standard statistical design and analysis methods to address project-specific challenges.
• Experience developing and reviewing statistical analysis plans (SAPs) and independently running analyses for complex studies with minimal oversight.
• Proficiency in R and other relevant statistical software, with experience in code review and validation.
• Excellent communication, organizational, and problem-solving skills.

Skills

• Advanced statistical analysis methods.
• Survival analysis.
• Experimental design.
• Statistical programming proficiency (R).
• Project management and leadership skills.
• Interdisciplinary collaboration.

Benefits

• Full range of benefits, including incentive compensation, restricted stock units, medical and other benefits.
• Reasonably believes that criminal history may have a direct, adverse and negative relationship on certain job duties.
• Equal opportunity employer.