Statistical lead developing biostatistical support for drug and vaccine projects in R&D. Interacting with multiple disciplines to ensure effective clinical trial design and analysis.
Responsibilities
Serves as a statistical lead in project teams.
Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.
Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Scientists from our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.
Prepares oral and written reports to communicate results of clinical trials to the project team, our Company Management, regulatory agencies, or individual investigators.
Requirements
PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.
Solid knowledge of statistical analysis methodologies and experimental design.
Strong scientific leadership in design and analysis of clinical trials.
Strong project management skills.
Solid knowledge of statistical and data processing software e.g. SAS and/or R.
Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
Excellent oral and written communication skills and strong leadership in a team environment.
Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
Publications in peer reviewed statistical/medical journals.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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