Associate Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with cross-functional teams on hematology research projects.

• Engage with Clinical, Regulatory, Statistical Programming, Data Management, and other Research Scientists.

• Evaluate data and create as well as execute statistical analysis plans for clinical study reports and submissions to health authorities.

• Contribute content for manuscripts and presentations.

• Offer statistical guidance in the design and analysis of clinical trials.

• Organize statistical tasks for clinical initiatives.

• Develop or aid in the development of study protocols and statistical analysis strategies.

• Identify suitable statistical methodologies for data evaluation.

• Join database design discussions to ensure data integrity and analysis appropriateness.

• Partner with statistical programming teams to ensure that programs fulfill analysis, internal SOP, and regulatory standards.

• Analyze and interpret clinical trial data under supervision.

• Create both oral and written reports to communicate clinical trial findings.

• Address study design, analysis, and interpretation inquiries from clinical monitors, regulatory bodies, and investigators.

• Engage in research focusing on innovative statistical methods and applications in clinical trial development.

⛳️ Requirements

• PhD in Statistics or a related discipline with over 5 years of experience, or a Master’s degree with at least 8 years of experience in clinical drug development.

• Experience with clinical trials.

• Familiarity with regulatory guidance.

• Proficiency in SAS and/or R is highly desirable.

• Experience in oncology is preferred but not mandatory.

• Proven written and verbal communication skills.

• Ability to collaborate within a team as well as work autonomously.

• Strong analytical and interdependent thinking skills.

• Capacity to foster strategic working relationships.

• Excellent decision-making abilities.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Access to an incentive compensation plan for commercial roles.

• Potential for discretionary equity awards.

• Participation in a Voluntary Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance options.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.

• Life insurance provided.

• Paid Time Off (PTO).

• Wellness benefits available.