Principal Biostatistician

As a Principal Biostatistician, you will be part of the Medical Affairs team, fostering collaboration to generate evidence-based clinical practices and innovate solutions for patients with cardiovascular disease. The role involves representing Biostatistics on clinical development, providing statistical expertise, and advising on clinical studies, data quality assurance, and regulatory submissions.

Requirements

• Ph.D. or equivalent in Statistics, Biostatistics, or related field
• 2 years of experience
• Training or publications in Bayesian methodology
• Expertise in MS Office (Word, PowerPoint, Access, Excel)
• Strong written/verbal communication and relationship management skills
• Up-to-date on statistical and regulatory developments
• Deep knowledge of clinical trial design, statistical modeling, and data analysis
• Proficient in SAS; experience with R, S-Plus
• Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices
• Excellent problem-solving, analytical, and critical thinking skills
• Proven leadership and ability to influence change
• Skilled in training/coaching and facilitating organizational change
• Detail-oriented; able to manage competing priorities in fast-paced environments
• Professional interaction across all levels; collaborative team player and consultant to management

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs