Associate Director, Biostatistics

Job Description

As an Associate Director of Biostatistics, you will play a crucial role in clinical development. Responsibilities include: - Serving as a statistical expert in cross-functional teams, guiding strategic planning and execution for product development. - Contributing to clinical development planning to ensure study designs align with program goals and meet global regulatory and marketing standards. - Proactively identifying and addressing technical challenges in clinical trial design, conduct, and analysis, proposing and implementing solutions. - Developing study protocols and data analysis plans, selecting appropriate statistical methodologies. - Analyzing clinical trial data and interpreting results to achieve study protocol objectives. - Applying statistical techniques to analyze data effectively. - Creating comprehensive reports to communicate clinical trial outcomes to teams, management, and regulatory bodies. - Addressing inquiries on study design and analysis from clinical monitors and regulatory agencies. - Overseeing the accuracy of statistical review aids for regulatory submissions. - Participating in research to develop innovative statistical methods for clinical trials.

Qualifications

To succeed as an Associate Director, Biostatistics, the following is required: 1. A PhD in Statistics or a related field with 4+ years of experience, or a Master’s degree with 6+ years of experience in clinical drug development. 2. Experience with clinical trials and knowledge of regulatory guidance. 3. Experience in oncology is preferred. 4. Excellent written and oral communication skills, with the ability to work independently and collaboratively in a team. 5. Strong analytical thinking, strategic relationship-building, and decision-making skills.

Benefits

BeOne offers a competitive benefits package: - Medical coverage - Dental coverage - Vision coverage - 401(k) plan - Flexible Spending Account (FSA) and Health Savings Account (HSA) - Life Insurance - Generous Paid Time Off (PTO) - Wellness programs