Biostatistician

Remote- Early Phase Biostatistician

The Biostatistician will be responsible for providing statistical support for clinical trials conducted within the pharmaceutical industry. The successful candidate will work closely with the clinical research team to design studies, develop statistical analysis plans, and conduct statistical analyses. The Biostatistician will also be responsible for interpreting results and communicating findings to stakeholders.

Key Responsibilities:

• Design and develop statistical analysis plans for clinical studies
• Conduct statistical analyses using SAS software
• Provide statistical support for clinical trial protocols, case report forms, and study reports
• Collaborate with clinical research teams to ensure study design is appropriate for statistical analysis
• Analyze and interpret study data, and communicate findings to stakeholders
• Prepare statistical sections of regulatory documents, such as Clinical Study Reports and New Drug Applications
• Ensure compliance with regulatory requirements and guidelines
• Keep up-to-date with new statistical methods and software, as well as regulatory guidance.

Qualifications:

• Ph.D. in Biostatistics or equivalent
• 5 years of pharmaceutical biostatistics experience required
• Experience in SAS programming
• Excellent analytical and problem-solving skills
• Strong attention to detail and ability to work independently
• Excellent verbal and written communication skills
• Ability to work in a team environment and collaborate effectively with other stakeholders
• Knowledge of regulatory requirements for clinical trials and drug development.