Manager, Biostatistics

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Deliver expert technical and strategic direction in the design, analysis, and interpretation of intricate clinical and real-world data studies, emphasizing high-impact initiatives.

• Engage in cross-functional collaboration with Engineering, Clinical/Medical, Data Science, and other stakeholders to ensure project success and convert research into actionable business and clinical insights.

• Spearhead the creation of statistical analysis plans, including sample size and power calculations, while recommending precise and effective statistical methodologies.

• Manage and independently conduct statistical analyses for highly complex studies, proactively identifying and resolving methodological challenges, and enhancing or modifying standard methods as required.

• Provide the necessary statistical support for any regulatory submissions.

• Work independently on complex issues, selecting and adapting innovative methods as suitable.

• Collaborate in an interdisciplinary capacity with scientists and engineers to transform research into actionable insights for our clients.

• Remain up-to-date with advancements in statistical methodologies, regulatory standards, and industry best practices pertinent to clinical trials and real-world data studies.

• Adhere to all regulations and company protocols.

• Mentor and guide both junior and senior biostatisticians, providing high-level project leadership and thorough technical review (e.g., SAP review, code validation).

⛳️ Requirements

• Ph.D. or Master’s Degree in Biostatistics, Statistics, or a related discipline coupled with 4+ years (Ph.D.) / 6+ years (MS/MA) of relevant industry experience.

• Proven expertise in advanced statistical analysis techniques, experimental design, and survival analysis, with substantial business domain knowledge in oncology, cardiology, and/or genomics.

• Established capability to enhance or extend standard statistical design and analysis methods to meet project-specific challenges.

• Experience in developing and reviewing statistical analysis plans (SAPs) and independently conducting analyses for complex studies with minimal supervision.

• Proficiency in R and other pertinent statistical software, along with experience in code review and validation.

• Exceptional communication, organizational, and problem-solving abilities.

🏝️ Benefits

• Medical and various other benefits.