Helios Cardio and Helios Aesthetics are dynamic organizations focused on advancing healthcare through innovative medical devices based upon a proven biologic platform. We are currently seeking a highly skilled and experienced Independent Biostatistician Consultant to collaborate with our team on a variety of exciting initiatives.

This is a project-based consulting opportunity ideal for an independent professional looking to contribute their expertise to impactful medical device development. The successful candidate will work closely with our in-house biometrics specialist and clinical project teams.

Key Responsibilities will include:

• Statistical Analysis Plan (SAP) Elaboration: Developing comprehensive and robust SAPs for medical device clinical studies, ensuring alignment with study objectives and regulatory requirements.
• Sample Size Justification: Performing power and sample size calculations to ensure studies are adequately powered to meet their endpoints.
• Data Analysis: Analyzing clinical trial datasets provided by our biometrics specialist, interpreting results, and preparing statistical reports.
• Collaboration and Support: Providing statistical expertise and guidance to clinical project teams throughout the lifecycle of the studies.

Qualifications and Experience:

• Advanced degree (Master's or PhD) in Biostatistics, Statistics, or a related field.
• Proven experience as a Biostatistician, with a strong portfolio of work in the medical device industry.
• Demonstrated expertise in the development of Statistical Analysis Plans and sample size calculations for clinical trials.
• Proficiency in statistical software (e.g., SAS, R).
• Thorough understanding of relevant regulatory guidelines for medical devices (e.g., FDA, ISO).
• Experience analyzing clinical trial data and generating clear, concise statistical reports.
• Excellent communication and interpersonal skills, with the ability to explain complex statistical concepts to non-statistical audiences.
• Ability to work independently and manage timelines effectively

Apply Online here