Associate Director, Biostatistics
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Job Description
Associate Director, Biostatistics supporting BeOne’s hematology clinical trials and cancer drug development. Developing SAPs, analyzing trial data, and supporting regulatory submissions.
Responsibilities:
- 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 to ensure data quality and analysis suitability
- Collaborate with statistical programming staff to ensure programs meet analysis, internal SOP, and regulatory requirements
- Analyze and interpret clinical trial data under supervision
- 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 on innovative statistical methods and applications in clinical trial development
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
- Knowledge of regulatory guidance
- Knowledge of SAS and/or R is strongly desirable
- Oncology experience is preferred but not required
- Demonstrated written and oral communication skills
- Ability to work within a team and work independently
- Interdependent/analytic thinking skills
- Ability to build strategic working relationships
- Good decision-making capability
Benefits:
- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Voluntary Employee Stock Purchase Plan participation
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits
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