Associate Director, Biostatistics

Job Description:

• Work with cross-functional study/project teams supporting hematology studies
• Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Research Scientists
• Review data and develop and implement statistical analysis plans for clinical study reports and health authority submission documents
• Provide content for manuscripts and presentations
• Provide statistical support in designing and analyzing clinical trials
• Coordinate statistical activities for clinical projects
• Develop or assist with developing study protocols and statistical analysis plans
• Determine appropriate statistical methodologies for data analysis
• Participate in database design meetings
• Collaborate with statistical programming staff to ensure programs meet analysis, SOP, and regulatory requirements
• Analyze and interpret clinical trial data
• Prepare oral and written reports communicating clinical trial results
• Respond to study design, analysis, and interpretation queries from clinical monitors, regulatory agencies, and investigators
• Participate in research activities involving innovative statistical methods and clinical trial applications

Requirements:

• PhD in Statistics or related field with 5+ years of experience, or a Master’s degree with a minimum of 8 years of experience in clinical drug development
• Experiences with clinical trials required
• Knowledge of regulatory guidance required
• Knowledge of SAS and/or R strongly desirable
• Oncology experience preferred but not required
• Demonstrated written and oral communication skills
• Ability to work within a team and work independently
• Interdependent/analytic thinking skills
• Strategic working relationship-building skills
• Good decision-making capability
• Travel not required

Benefits:

• Annual bonus plan eligibility for non-commercial roles
• Incentive compensation plan eligibility for commercial roles
• Discretionary equity awards
• Employee Stock Purchase Plan
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness