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.
** Principal Scientist, Biostatistics
**** Responsibilities:
*** Serve as a statistical lead in project teams.
* Develop, coordinate, and provide biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
* Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Research & Development Division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
* Interact with Academic Research Organization (ARO), Contract Research Organization (CRO), and external statistical consultants.
* Serve as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development.
* Participate in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
* Independently 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 analysis.
* Participate in database design meetings to ensure that the data evaluated are of high quality and satisfy analysis requirements.
* 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.
* 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 clinical trials to meet objectives of the study protocol. Independently apply and implement basic and complex statistical 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 individual investigators.
* Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
* Represent biostatistics in regulatory interactions including presentation at advisory committee meetings.
* Plan and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies.
* Participate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
* Engage in research activities for innovative statistical methods and applications in clinical trial development.
* Mentor and guide junior staff in functional activities.
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* Education Requirements:

*** PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master’s degree with a minimum of 9 years relevant work experience.
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* Qualifications:

*** Required
* * Solid knowledge of statistical analysis methodologies and experimental design.
* Strong project management skills.
* Solid knowledge of statistical and data processing software (e.g., SAS or R).
* Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
* Strong oral and written communication skills. Able to function effectively in a team environment.
* Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
* Solid knowledge and strong interest in exploring applications of AI/ML to the…