Principal Biostatistician, Oncology Clinical Trials

$150,000 - $185,000/Yr

Td2 - Scottsdale, AZ

Full-time - Senior

Remote - Scottsdale, AZ

Real Estate

About the position

The Principal Biostatistician position at TD2 is a senior-level role focused on providing biostatistical support for oncology clinical trials. The role involves collaborating with sponsors and study teams to ensure high-quality data analysis and integrity throughout the clinical trial process. The Principal Biostatistician will be responsible for statistical planning, analysis, and reporting, while also overseeing junior staff and contributing to regulatory submissions and publications.

Responsibilities

• Serve as the key point of contact for sponsors and study teams regarding biostatistics activities in clinical trials.
• Contribute to trial planning as a statistical consultant, advising on study design and sample size calculations.
• Write and review Statistical Considerations sections for clinical trial protocols.
• Independently develop statistical analysis plans (SAPs) and design templates for statistical tables and reports.
• Review and edit SAPs created by team members.
• Perform statistical analyses and interpret results, overseeing analyses conducted by junior staff.
• Prepare statistical summary reports and write statistical methods sections for integrated study reports.
• Review and approve draft integrated study reports, ensuring documentation is complete and archived.
• Work with project teams to identify statistical issues and propose solutions.
• Provide statistical input for study reports, regulatory documents, and publications.
• Research and apply new statistical methodologies as needed.
• Represent TD2 in sponsor meetings and quality audits related to biostatistics activities.

Requirements

• Master's degree in Biostatistics/Statistics required; Ph.D. preferred.
• Minimum of 8 years of relevant experience in the biopharmaceutical industry.
• Experience in early phase oncology trials preferred.
• Hands-on experience as a Study Statistician (at least 6 years) or Lead Statistician (at least 2 years).
• Understanding of all phases of oncology clinical trials and vendor oversight experience.
• Knowledge of FDA and ICH requirements and industry standards for clinical trials.
• Proficiency in SAS programming and experience with statistical software such as R.

Nice-to-haves

• Experience with adaptive clinical trial designs.
• Experience in complex therapeutic areas like rare diseases or cardiac trials.
• Experience with regulatory submissions and Health Authority interactions.
• Skills in Microsoft Excel and Word.

Benefits

• Competitive salary ranging from $150,000 to $185,000 per year.
• Remote work flexibility.
• Equal opportunity employer with a commitment to diversity and inclusion.