Senior Biostatistician

Biostatistician

Job Summary: We are seeking an experienced Medical Device Biostatistician Consultant with over 7 years of expertise in the medical device industry, specializing in biostatistics. The ideal candidate will possess a strong proficiency in SAS programming and will be adaptable to learn our client's proprietary internal systems. This role involves collaborating with cross-functional teams to provide statistical support and ensure the integrity and validity of clinical trial data.

Key Responsibilities:

• Provide statistical consulting and support for clinical trials and regulatory submissions in the medical device sector.
• Develop and execute statistical analysis plans (SAPs) for clinical studies, ensuring compliance with regulatory standards and guidelines.
• Perform statistical analyses using SAS programming, ensuring accurate and timely delivery of results.
• Collaborate with clinical, regulatory, and data management teams to design, implement, and monitor clinical studies.
• Review and provide input on study protocols, case report forms (CRFs), and data management plans.
• Conduct sample size calculations, power analysis, and other statistical methodologies to support study design.
• Generate and review statistical reports, including tables, listings, and figures, for clinical trial results.
• Ensure data integrity and adherence to Good Clinical Practice (GCP) and other relevant regulations.
• Participate in the preparation of regulatory submissions, including statistical sections of investigational device exemptions (IDEs), premarket approvals (PMAs), and 510(k) submissions.
• Train and mentor junior statisticians and other team members as needed.
• Qualifications:Master's or PhD in Biostatistics, Statistics, or a related field.
• A minimum of 7 years of biostatistics experience in the medical device industry.
• Extensive experience with SAS programming for statistical analysis.
• Strong understanding of clinical trial design, methodology, and regulatory requirements (FDA, ISO, etc.).
• Excellent problem-solving skills and attention to detail.
• Ability to work independently and as part of a team.
• Strong communication skills, both written and verbal, with the ability to present complex statistical concepts to non-statistical audiences.
• Flexibility to learn and adapt to the client's internal systems and processes.
• Preferred Skills:Experience with other statistical software (e.g., R, SPSS) is a plus.
• Familiarity with machine learning and advanced statistical modeling techniques.
• Prior experience in training and mentoring junior statisticians.