Associate Director, Biostatistics

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

📋 Description

• Collaborate with diverse study and project teams to support hematology research.

• 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 documents for health authority submissions.

• Contribute content for manuscripts and presentations.

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

• Oversee statistical activities for clinical projects.

• Develop or assist in the creation of study protocols and statistical analysis plans.

• Identify suitable statistical methodologies for data analysis.

• Take part in database design meetings to ensure data quality and the fulfillment of analysis requirements.

• Collaborate with statistical programming personnel to ensure that programs align with analysis, internal standard operating procedures, and regulatory standards.

• Analyze clinical trial data and interpret the findings under supervision.

• Prepare both oral and written reports to convey clinical trial outcomes.

• Address queries related to study design, analysis, and interpretation from clinical monitors, regulatory bodies, and investigators.

• Engage in research initiatives focused on innovative statistical methods and their applications in clinical trial development.

⛳️ Requirements

• PhD in Statistics or a related field 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 is essential.

• Familiarity with regulatory guidelines is required.

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

• Oncology background is preferred but not mandatory.

• Proven written and verbal communication skills.

• Capacity to work effectively within a team as well as independently.

• Strong interdependent and analytical thinking abilities.

• Competence in establishing strategic working relationships.

• Effective decision-making skills.

🏝️ Benefits

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

• Participation in an incentive compensation plan for commercial roles.

• Access to discretionary equity awards.

• Employee Stock Purchase Plan participation.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account options.

• Life insurance coverage.

• Paid Time Off.

• Wellness programs.