Senior Scientist, Biostatistics

Responsibilities

• 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.
• The incumbent may initially work in a specific disease therapeutic area.
• Primary activities :
• 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
• Education and Minimum Requirement:
• PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master's degree with a minimum of 3 years relevant experience.
• Required Skills and Experience :
• Knowledge of statistical analysis methodologies and experimental design.
• Working knowledge of statistical and data processing software e.g. SAS and/or R.
• Good oral and written communication skills. Able to work effectively with personnel with different functional background.
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
• Preferred Skills and Experience :
• An understanding of biology of disease and drug discovery and development.
• BARDS2020
• #eligibleforERP
• Required Skills:
• Data Management, Data Science, Numerical Analysis, Scientific Modeling, Statistical Analysis, Statistical Research, Statistics
• Preferred Skills:
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• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only:
• Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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• EEOC GINA Supplement

Benefits

Additional Information

Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

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