Senior Scientist, Biostatistics

Requirements

• Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other Scientists part of our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
• Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
• Develops individual protocols and data analysis plans 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.
• Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.
• Independently applies and implements basic and complex techniques to these analyses.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
• Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Involved in research activities for innovative statistical methods and applications in clinical trial development

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days