Principal Scientist, Biostatistics, Late-Stage Clinical Development Full-time

Principal Scientist In Biostatistics

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.

This position is for a principal scientist in biostatistics. The candidate should have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials. The knowledge must be sufficient to ensure that sound scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.

This position involves interaction with Medical, Data Coordination, Statistical Programming, our Research & Development Division scientists and Regulatory staffs in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development project as needed. More specifically:

• Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management. Lead a team of staff assigned to the project as needed. This includes the following activities:
• Is involved in late clinical development planning (LDP) to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
• 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 data analysis.
• Participates in Worksheet development, database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements.
• Determines the statistical programming needs and organizes the programming activities to ensure that all programs meet analysis requirements, internal standard operating procedures, validation, 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 experiments 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, our Company's Management, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, or investigators.
• Responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participates with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Collaborates in publication of research results in areas of applications.
• Independently conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods and develops new methods.
• Maintains technical skills and increases own knowledge of new methods or areas of applications by reading journals and attending professional society meetings. Presents own research at meetings and seminars. Communicates with statisticians outside our Company's concerning technical problems.
• Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical groups, department research effort, and other committee works, etc., as needed.

Position Qualifications :

• Education Minimum Requirement:
• Ph.D. (preferred) or MS in Biostatistics or Statistics
• Required Experience and Skills :
• With a MS, a minimum of 9 years relevant work experience; with a Ph.D., a minimum of 6 years relevant work experience.
• Preferred Experience and Skills:
• Scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for approval of drug/vaccine products; Regulatory submission experience strongly preferred; Prior experiences with respiratory and immunology disease areas are desired.

Required Skills:

Biostatistics, Clinical Trial Management, Clinical Trials, Clinical Trials Analysis, Computing Software, Data Management, Data Science, Numerical Analysis, Regulatory Compliance, Regulatory Requirements, Scientific Leadership, Scientific Modeling, Standard Operating Procedure (SOP), Statistical Analysis

Preferred Skills: