Sr. Principal Biostatistician

About This Role

As a Senior Principal Biostatistician, you will be at the forefront of leading study design and data analysis, providing statistical expertise for our products across various therapeutic areas. Your role is crucial in clinical development, biomarker development, research, and beyond. Acting independently, you will provide statistical input in scientific discussions, participate in protocol development, and oversee analysis plans and report specifications. You'll play a key role in reviewing study setup activities, ensuring the integrity of randomization and CRFs, and leading biostatistical efforts for assigned projects. Your work involves performing statistical analyses, interpreting results, and preparing comprehensive clinical study reports. Additionally, you'll assist in preparing responses to statistical issues in regulatory or legal settings and liaise with clinical research personnel to align statistical support with our development strategy. Your contributions to process improvement initiatives and mentorship will aid in the long-term growth of our department.

What You’ll Do

• Lead biostatistics representation on project or study teams and provide statistical expertise.
• Define statistical methodologies, analyze data, and report results for clinical development plans.
• Train and supervise contract statisticians, ensuring quality deliverables.
• Aid in addressing statistical issues in regulatory, legal, or other challenges.
• Serve as a peer reviewer and internal consultant on broad statistical issues.
• Participate in process improvement initiatives and mentor new/junior biostatisticians.
• Conduct modeling and simulations as needed.
• Collaborate closely with study or project teams for data interpretation and reporting.
• Work with statistical programmers, data management, and vendors to deliver analysis results.
• Collaborate with medical writers to complete study reports and manuscripts.
• Supervise FSP statisticians in assigned tasks.

Who You Are

You are a detail-oriented individual with a strong analytical mindset, capable of managing multiple projects simultaneously. Your ability to effectively communicate complex statistical concepts in lay terms sets you apart, alongside your leadership skills and ability to work collaboratively with diverse teams. Your proactive approach to problem-solving and your dedication to continuous learning in statistical methodologies make you an invaluable asset.

Required Skills

• PhD in Biostatistics or equivalent with a minimum of 3+ years relevant work experience in the pharmaceutical/biotech industry.
• Thorough understanding of statistical principles and clinical trial methodology.
• Ability to provide technical solutions to a wide range of difficult problems.
• Conversant with R, SAS, or other statistical software programming languages.
• Working knowledge of regulatory guidelines related to statistical analysis.
• Strong ability to manage multiple projects and conflicting priorities.
• Excellent written and verbal communication skills.

Preferred Skills

• Experience with statistical components of regulatory submissions.
• Detailed knowledge of R or SAS procedures and computing tools for modeling and simulations.
• Prominent experience in mentoring junior staff and contributing to process improvements.