Principal Biostatistician

Principal Biostatistician position supporting clinical research and regulatory submissions for transcatheter cardiac therapies. Will lead statistical analyses on multiple clinical trials, collaborate with cross-functional teams, and mentor junior statisticians while contributing to process standardization.

Responsibilities

• Lead statistical analyses for multiple clinical trials and coordinate study report documentation
• Provide biostatistical expertise for new product development and regulatory submissions (PMA, CE Mark, PMDA)
• Research and recommend novel statistical methodologies and approaches for clinical data
• Mentor junior statisticians and support resource allocation and budget planning
• Develop and standardize biostatistics SOPs and work instruction manuals

Requirements

• Ph.D. in Statistics, Biostatistics, or related field with 2+ years experience
• Master's degree in Statistics, Biostatistics, or related field with 5+ years clinical trial experience
• Proficiency in R and statistical software packages
• CDISC standards knowledge (SDTM, ADaM) for regulatory-compliant analysis
• Expert knowledge of clinical trial design, statistical modeling, and regulatory guidelines (GCP, ICH, FDA, ISO)
• Strong leadership and mentoring capabilities
• Excellent written and verbal communication skills

Compensation: $132,000–$186,000 base