Finance Analyst – SG&A
Vita Coco
Associate Director, Biostatistics
BeOne Medicines
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $156,800 - $206,800 per year
Job Level
Senior
About the role
- 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
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
