Principal 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. This position is for a principal scientist in biostatistics.

The candidate must possess solid knowledge of statistical methodology, experimental design, computing software and data management, a general understanding of worldwide regulatory requirements, and good clinical trial experience in Phase II/III trials. The knowledge must be sufficient to ensure sound scientific principles and statistical methods are applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.

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

• Develop, coordinate, and provide biostatistical support for drug projects under the supervision of management.
• Lead a team of staff assigned to the project as needed.
• Participate in late clinical development planning (LDP) to ensure study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
• Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of clinical trials, propose solutions and carry them out.
• Develop individual protocols and data analysis plans and independently determine appropriate statistical methodology for data analysis.
• Participate in worksheet development and database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information, and satisfy analysis requirements.
• Determine the statistical programming needs and organize programming activities to ensure all programs meet analysis requirements, internal SOPs, validation, and external regulatory requirements.
• Evaluate the appropriateness of available software for planned analyses and ascertain needs for potential program development of novel statistical methodology.
• Analyze data and interpret results from experiments to meet objectives of the study protocol.
• Independently apply and implement basic and complex techniques to these analyses.
• Prepare oral and written reports to effectively communicate results of clinical trials to the project team, company management, regulatory agencies, or investigators.
• Provide responses to queries relating to study design, analysis, and interpretation posed by clinical monitors, regulatory agencies, or investigators.
• Ensure the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participate with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Collaborate in publication of research results in areas of application.
• Independently conduct research on statistical methodology, pursue solutions to various technical problems, adapt known methods and develop new methods.
• Maintain technical skills and increase own knowledge of new methods or areas of application by reading journals and attending professional society meetings.
• Present own research at meetings and seminars.
• Communicate with statisticians outside the company concerning technical problems.
• Participate in departmental activities including recruiting and training other statisticians, providing statistical training for non‑statistical groups, department research effort, and other committee work.

Minimum Requirement:
Ph.D. (preferred) or MS in Biostatistics or Statistics.

• With an MS, a minimum of 9 years relevant work…