Principal Biostatistician

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:

• Serves as a statistical lead in project teams.

• Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.

• Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our company's Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

• May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.

• The incumbent may initially work in a specific disease area.

Primary activities:

• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development 

• Is involved in clinical development planning 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 analysis.

• Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.

• May lead a team of statisticians and 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 statistical 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, and/or investigators.

• May represent biostatistics in regulatory interactions including presentation at advisory committee meetings 

• 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 …