Senior Scientist, Biostatistics

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.

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 of our company's Research Laboratories Scientists 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.

Minimum education required:

PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master’s degree with a minimum of 3 years relevant experience. 

Required experience and skills:

• 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 …