BeOne Medicines
Cancer has no borders. Neither do we.
Associate Director, Biostatistics
Location
United States
Posted
175 days ago
Salary
$156.8K - $206.8K / year
Seniority
Senior
Postgraduate Degree4 yrs expEnglish
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 the data, develop and implement the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents
• Provide content for manuscripts / presentations
• Provide statistical support in designing and analyzing clinical trials
• Coordinate the statistical activities for clinical projects
• Develops or assists development of study protocols and SAPs and determines appropriate statistical methodology for data analysis
• Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements
• Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol
• Applies and implements basic and complex techniques to these analyses under supervision
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators
• Involved in research activities for innovative statistical methods and applications in clinical trial development
Job Requirements
- A minimum of a PhD in Statistics or related field
- 4+ years of experience in clinical drug development
- Experiences with clinical trials and knowledge of regulatory guidance
- Knowledge of SAS and/or R is strongly desirable
- Demonstrated written and oral communication skills
- Ability to work within a team and work independently
- Interdependent/analytic thinking skills
- Building strategic working relationships
- Good decision-making capability
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan (for Non-Commercial roles)
- Incentive compensation plan (for Commercial roles)
- Discretionary equity awards
- Employee Stock Purchase Plan
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